8432 results for "canc*"

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• Molecular Markers of Risk of Subsequent Invasive Breast Cancer in Women with Ductal Carcinoma in Situ

  Ductal carcinoma in situ (DCIS) is considered to be a non-obligate precursor of invasive breast cancer (IBC). Novel prognostic (and ultimately predictive) markers of IBC risk may emerge from assessment of expression patterns on a global scale. Our overarching goal in this study was to facilitate early detection of patients with DCIS at risk of IBC development. To this end, we conducted a nested case-control study using clinical data and archived formalin-fixed paraffin-embedded (FFPE) tissue from a large multi-center cohort of 8175 patients initially diagnosed with DCIS in community-based hospitals and health plans and followed for subsequent IBC development. Specifically, within this cohort, we observed that p16, COX-2, and MKI67 protein expression was not associated with altered risk of ipsilateral IBC. However, we did identify miRNA expression differences associated with risk of progression to subsequent IBC. Studies of this nature have the potential to lead to approaches that will help to refine identification of women with DCIS who need enhanced surveillance and early aggressive treatment.

  Study phs004440

• Women's Health Initiative (WHI) - Life and Longevity After Cancer (LILAC) (WHI-LILAC-BioLINCC)

  Data Access NOTE: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions. Objectives: The LILAC substudy was initiated to collect information on cancer treatment and long-term outcomes in women diagnosed with eight selected cancers during their participation in WHI.Background: Improvements in early detection and treatment have led to a surge in the number of cancer survivors in the United States creating a demand for a better understanding of their health concerns. Cancer survivor health concerns are diverse and complex due to the heterogeneity among individuals, cancer type, and treatment variability. To effectively examine these concerns, new resources need to be developed, including a much more comprehensive assessment on a large sample with longer-term follow-up than is typically available in cancer clinical trials. The WHI cohort, which is a large study with long-term follow-up, continues to be a good resource to study issues related to aging and health. The LILAC substudy was initiated with WHI participants who had been diagnosed with cancer to examine cancer survivorship among older women.Participants: Participants with no cancer (other than non-melanoma skin cancer) prior to enrollment in WHI and a confirmed invasive cancer diagnosis during WHI follow-up of one of the eight selected cancers were eligible for LILAC.A total of 9934 WHI participants living with cancer were eligible. Of those, 7751 consented and returned the baseline survey. This included 821 participants with melanoma, 781 participants with colorectal cancer, 648 participants with endometrial cancer, 397 participants with lung cancer, 4173 participants with breast cancer, 442 participants with non-Hodgkin lymphoma, 181 participants with leukemia, and 208 participants with EOC (which includes ovarian, fallopian tube and primary peritoneal cancers). Design: Participants still in active WHI follow-up who were eligible for the LILAC substudy were sent an invitational mailing that included a baseline survey. Baseline surveys collected data on initial cancer treatment, symptoms after treatment completion, and quality of life. WHI participants who consented to the LILAC substudy were subsequently sent annual surveys. Annual surveys collected any updates on treatment, as well as other topics related to cancer survivorship such as social support. Additional treatment information was obtained from Medicare claims and medical records.Conclusions: The LILAC substudy provides a resource for studying cancer survivorship among older women diagnosed with eight selected cancers.

  Study phs004174

• Study of Novel Approaches for Prevention (SNAP-BioLINCC)

  Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions.ObjectivesTo compare two self-regulation interventions versus control in reducing weight gain in young adults over an average follow-up of 3 years.BackgroundWeight gain occurs commonly throughout adulthood and has been associated with many adverse health outcomes. Weight gain in adults aged 18 – 35 years had stronger negative associations with critical outcomes such as cancer risk and mortality compared to weight gain at later ages. Developing effective approaches to reduce weight gain in young adults was therefore an important public health priority and focus of the SNAP study.ParticipantsSNAP targeted an enrollment of 600 participants (25% men and 25% racial / ethnic minorities), age 18–35, with a BMI of 21–30.9 kg/m2. Eligibility requirements focused on ability to participate in the program (e.g., internet access, English speaking), safety (no history of eating disorders, ability to walk for activity) and completion of screening and baseline assessment visits.Potential subjects were excluded due to pregnancy, diabetes, alcohol or substance dependence, psychiatric disorders, and any medical problem that could cause unintentional weight change.A total of 599 subjects were enrolled and randomly assigned into one of three treatment arms. 202 participants were enrolled in the control group, 197 assigned to the large changes group, and 200 assigned to the small changes group.DesignThe Study of Novel Approaches to Weight Gain Prevention (SNAP) was a 3-armed randomized controlled clinical trial that compared self-regulation with small daily behavior changes (Small Changes), self-regulation with large periodic behavior changes (Large Changes), and a minimal treatment control.The Control group attended one face-to-face meeting where they were introduced to the issue of weight gain, the concept of self-regulation, and an overview of both Small and Large Change approaches to potentially prevent weight gain.The Small and Large Changes interventions both began with 10 face-to-face group meetings over 4 months. Participants in Small Changes were taught to make daily small changes (approximately 100 kcal/day) in both diet and physical activity. Participants were given pedometers and instructed to add 2000 steps per day above their baseline activity level.Large Changes focused on losing weight during the initial four-month program to create a buffer against subsequent weight gain. To achieve this, participants were prescribed a calorie goal based on a 500- 1000 kcal deficit from baseline to use during the initial 8 weeks. They were also encouraged to gradually increase moderate intensity physical activity to a goal of 250 minutes/week, the level recommended for weight loss maintenance.All participants were scheduled to complete assessments at baseline, month 4, year 1 and year 2. To encourage self-regulation, participants were instructed to weigh themselves daily and submit their weight via the study website, text message or email. They received monthly email feedback on their weight, which was based on a color-coded system and either reinforced their success, encouraged problem-solving, or recommended additional strategies to help reverse weight gain. Each year, participants were invited to join two 4-week online refresher campaigns reinforcing the behaviors taught during the initial program. All participants received identical quarterly newsletters and personalized feedback reports on their assessment data, including the Control group.The primary outcome was the mean weight gain over an average follow-up of 3 years. Secondary outcomes were the proportion of participants gaining ≥1 pound (chosen to represent a stringent criterion of weight gain over baseline) and the incidence of obesity (BMI≥30 kg/m2) over the 3 years.ConclusionsSelf-regulation interventions involving small or large changes were both effective in reducing the mean weight gain relative to control over an average follow-up of 3 years. The Large Changes intervention successfully decreased the proportion of participants who experienced weight gains ≥1 pound over the follow-up, and both interventions reduced the incidence of obesity during follow-up by almost 50% relative to Control, representing a clinically significant reduction in risk of developing obesity.Wing RR, Tate DF, Espeland MA, et al. Innovative Self-Regulation Strategies to Reduce Weight Gain in Young Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized Clinical Trial. JAMA Intern Med. 2016;176(6):755-762. doi:10.1001/jamainternmed.2016.1236

  Study phs004682

• Blood and Marrow Transplant Clinical Trials Network - A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN-1703-BioLINCC)

  Data Access NOTE: Please refer to the “Authorized Access” section below for information about how access to the data from this accession differs from many other dbGaP accessions.Objectives: To compare two graft-vs.-host-disease prophylaxis strategies in patients undergoing hematopoietic stem cell transplantation after reduced-intensity conditioning.Background: The combination of methotrexate and a calcineurin inhibitor has been the standard of care for graft-vs.-host disease (GVHD) prevention in patients undergoing allogeneic transplantation. However, acute GVHD, chronic GVHD, or both develop in more than half of these patients, resulting in complications and death.In 2013, the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) launched a phase 2 clinical trial (BMT CTN 1203) comparing three different GVHD prophylaxis strategies with a contemporaneous control regimen of tacrolimus/methotrexate (Tac/MTX) in patients undergoing hematopoietic stem cell transplantation (HSCT) after reduced-intensity conditioning (RIC). That trial identified the combination of cyclophosphamide/tacrolimus/mycophenolate mofetil (PTCy/Tac/MMF) as the most promising regimen. BMT CTN 1703 was a phase 3 follow up study initiated to compare PTCy/Tac/MMF to Tac/MTX.Participants: Eligible participants were aged 18 years or older and undergoing their first allogeneic transplantation. Eligible diagnoses included: acute leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow or myelodysplasia or chronic myelomonocytic leukemia with no circulating blasts and fewer than 10% blasts in the bone marrow, chronic lymphocytic leukemia or small lymphocytic lymphoma, or lymphomas that were sensitive to therapy.A total of 431 participants were enrolled and underwent randomization. 214 participants were assigned to receive experimental prophylaxis and 217 participants were assigned to receive standard prophylaxis.Design: The BMT-CTN 1703 study was a randomized, multicenter Phase 3 clinical trial. Participants with hematologic cancers were randomly assigned in a 1:1 ratio to receive PTCy/Tac/MMF (experimental prophylaxis) or Tac/MTX (standard prophylaxis). The participants underwent HSCT from an HLA-matched related donor or a matched or 7/8 mismatched (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) unrelated donor, after reduced-intensity conditioning.The experimental prophylaxis regimen consisted of the following: cyclophosphamide (50 mg per kilogram per day on days 3 and 4 after HSCT); tacrolimus starting on day 5 (orally at a dose of 0.05 to 0.06 mg per kilogram per day or intravenously at a dose of 0.02 to 0.03 mg per kilogram per day; taper could start on day 90 with a goal of discontinuation by day 180); and mycophenolate mofetil (15 mg per kilogram per dose orally or intravenously), not to exceed 1 g thrice daily, starting on day 5 to day 35. The standard-prophylaxis regimen consisted of methotrexate (an intravenous bolus of 15 mg per square meter on day 1 and an intravenous bolus of 10 mg per square meter on days 3, 6, and 11) and tacrolimus (dose as above, starting 3 days before HSCT; taper could start on day 90 with a goal of discontinuation by day 180).The primary end point was GVHD-free, relapse-free survival at 1 year, assessed in a time-to-event analysis, with events defined as grade III or IV acute GVHD, chronic GVHD warranting systemic immunosuppression, disease relapse or progression, and death from any cause.Conclusions: Among patients undergoing allogeneic HLA-matched HSCT with reduced-intensity conditioning, GVHD-free, relapse-free survival at 1 year was significantly more common among those who received cyclophosphamide/tacrolimus/mycophenolate mofetil than among those who received tacrolimus/methotrexate.

  Study phs004711

• Inherited Genetic Susceptibility in Langerhans Cell Histiocytosis

  We recruited cases of Langerhans cell histiocytosis (LCH) who were recruited to the Children's Oncology Group Childhood Cancer Research Network, Project:EveryChild projects, or to a local patient biobank to conduct an expanded genome-wide association study for risk variants and to perform post-GWAS analysis of a previous hit in the SMAD6 gene. Publicly available control data were used for our analyses; however, here we provide the SNP array data and targeted SMAD6 sequence data for the LCH cases and some non-LCH cases included in the analysis.

  Study phs004547

• Personalized DNA and Peptide Vaccines Elicit Neoantigen-Driven T-Cell Responses in Pancreatic Cancer

  This study provides data from two phase I clinical trials (NCT03122106, NCT03956056) that evaluated the safety and immunogenicity of DNA-based and synthetic long peptide personalized cancer vaccines. Exome and RNA sequence data were used to identify somatic mutations, predict neoantigens, and design personalized cancer vaccines. Immune monitoring was performed on each patient to assess neoantigen specific T-cell responses.

  Study phs004463

• Durvalumab and Cediranib with and without Olaparib in Recurrent Ovarian Cancer: A phase II Proof-of-Concept Study

  We report the efficacy and translational research findings of durvalumab, olaparib, and cediranib (D+O+C) and durvalumab and cediranib (D+C) therapies from the recurrent epithelial ovarian cancer (EOC) cohort within a single center, multi-arm, non-randomized, multi-cohort phase I/II trial (NCT02484404). Sixty-eight patients were enrolled (39 in D+O+C, 29 in D+C). The objective response rate (ORR) was 19.4% (95% CI, 9.5-43.5) for D+O+C and 29.6% (95% CI, 13.8-46.9) for D+C. Median progression-free survival (PFS) was 4.5 months in both arms, with each arm including four exceptional responders (PFS ≥ 12 months). Pre-treatment biopsies and paired normal peripheral blood mononuclear cells (PBMC) samples for whole exome sequencing (WES) were available for 31 patients in the D+O+C and 24 in the D+C, the remaining 13 patients were not biopsied due to safety concerns or being off treatment. WES was conducted to explore genomic profiles for potential correlations with clinical benefit (CB; partial response or stable disease [SD] with PFS ≥ 4 months) or no clinical benefit (NCB; progressive disease or SD with PFS TP53 mutations were found in most cases in both D+O+C and D+C arms. Overall, no consistent associations between baseline genomic alterations and CB were observed.

  Study phs004519

• PIGR+RORC+ Dendritic Cells (PRDCs) are an Immunomodulatory Subset Enriched in Malignant Ascites

  Malignant ascites is caused by the peritoneal dissemination of cancer and associated with a poor prognosis. We sought to identify unique features of the ascites microenvironment and leveraged single-cell RNA sequencing in patients with ascites from gastroesophageal adenocarcinoma. We identified a dendritic cell (DC) subset that expresses RORC and found that this subset exists in low abundance in human tissues but is enriched in malignant ascites from multiple tumor histologies. Cellular Indexing of Transcriptomes and Epitopes by sequencing (CITEseq) data from ascites samples and matched PBMCs are available through dbGaP.

  Study phs004309

• NCTN: Dexamethasone Compared with Prednisone During Induction Therapy and Methotrexate with or without Leucovorin During Maintenance Therapy in Treating Patients with Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (AALL0232)

  Study ID: AALL0232NCT Number: NCT00075725 Children's Oncology Group (COG)Submitted in collaboration with the NCTN/NCORP Data Archive Trial Title: NCTN: Dexamethasone Compared with Prednisone during Induction Therapy and Methotrexate with or without Leucovorin during Maintenance Therapy in Treating Patients with Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (AALL0232)Trial Description: This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia. Clinical data presented in the following publication(s):PMID 27114587Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Lymphoblastic LeukemiaClinical Dataset(s) included:NCT00075725-D1 (PMID 27114587): There are three datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3): NCT00075725-D1 includes all patients enrolled on the study. This dataset contains baseline characteristics, BCR-ABL fusion status, MLL rearrangement, bone marrow status at end of induction, and survival data.NCT00075725-D2 (PMID 27114587): There are 3 datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3). NCT00075725-D2 is the subset of patients included in the randomized comparison between Capizzi and High-dose Methotrexate. The dataset includes baseline characteristics, BCR-ABL fusion status, MLL rearrangement, bone marrow status at end of induction, and survival data. Outcomes (EFS time, EFS indicator) in this dataset are different from the outcomes in NCT00075725-D1. The outcome of those assigned to Capizzi who subsequently received High-dose Methotrexate was censored at time of therapy crossover, since in AALL0232, therapy changes were recommended to provide HD-MTX to all participants who had not yet completed maintenance course 1 or received cranial irradiation.NCT00075725-D3 (PMID 27114587): There are three datasets associated with this publication (NCT00075725-D1, NCT00075725-D2, and NCT00075725-D3). NCT00075725-D3 is the toxicity data observed in the randomized cohorts (steroid and methotrexate).Additional whole genome genotyping data for this trial is available under phs001350.You are encouraged to view the PDF data dictionaries found in the “Documents” tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

  Study phs004039

• Global Health Centers of Excellence-New Delhi (GHCoE New Delhi-BioLINCC)

  Data Access NOTE: Please refer to the "Authorized Access" section below for information about how access to the data from this accession differs from many other dbGaP accessions. ObjectivesProtocol 1 To develop a model surveillance system for cardio-metabolic diseases (CMD) and their risk factors which can be adopted for continuing surveillance by other countries in South East Asia. To measure the incidence of CMD risk factors and disease events, as well as the associated morbidity and mortality. Protocol 2 To test whether an intensive and comprehensive health care intervention to reduce cardiovascular disease (CVD) risk among type 2 diabetes patients in South Asia is more effective and sustainable compared to existing care.Protocol 3 To develop a model surveillance system for cardio-metabolic diseases (CMD) and their risk factors in rural India. To measure the incidence of CMD risk factors and disease events, as well as the associated morbidity and mortality.Background Although animal and ecologic studies have suggested a link between dietary fat and the incidence of breast cancer, previous observational studies have not yielded definitive results. In the Women's Health Initiative dietary trial, breast cancer incidence was not significantly different between the low-fat diet group and the control group. However, findings from previous studies in humans on the association between adolescent diet and breast cancer are inconsistent and self-reports of childhood diets may yield biased results. The DISC06 follow-up study explored the hypothesis that diet during adolescence may play a greater role in breast cancer risk than diet during adulthood by evaluating the longer-term effects of the DISC intervention during childhood and adolescence on subsequent biomarkers that have been associated with breast cancer risk in adults. Background Cardio-metabolic diseases (CMDs) include diabetes mellitus, cardiovascular disease, kidney disease and common risk factors that underlie these conditions such as central obesity, insulin resistance, glucose intolerance, dyslipidemia, and hypertension. CMDs are a growing global public health problem, with high mortality rates particularly in low- and middle-income countries. However, CMDs have the advantage of being predictable through identification of risk factors and also preventable through changes in lifestyle, particularly through healthy eating habits and regular physical activity. The greatest gains in prevention have been seen when early and target-driven interventions address multiple risk factors. However, achieving control of individual risk factors is poor, globally. Quality improvement schemes have shown promise in high-income countries, but were untested in South Asia at the time of these studies. In people of South Asian origin, diabetes, and CMD risk factors and events occur at younger ages and lower body mass indices when compared to other ethnic groups, and are rapidly increasing with socioeconomic and nutrition transitions. CVD is currently the leading cause of death in both urban and rural India. Prior to these studies, the major source of population level estimates of CMD risk factors, morbidity and mortality in India was ad hoc surveys. Such methods are limited by problems of sample design, lack of standardization, frequent measurement errors and incomplete reporting of results. A surveillance model of study would allow for more extensive comprehension of the distribution and trends of determinants and disease, dynamic integration of information from multiple sources, and aid in the development of safe, effective prevention and care models. Participants Protocol 1 Households within each study site were randomly selected. Any non-pregnant individuals permanently residing in the household and at least 20 years of age were eligible for enrollment. 4,943 participants from Chennai, 4,425 participants from New Delhi, and 4,016 participants from Karachi were enrolled in the first surveillance cohort. The study aimed to recruit 6,500 new participants at each of the three sites for the second cohort. Protocol 2 Eligible patients were at least 35 years of age with a diagnosis of diabetes, poor glycemic control (HbA1c ≥ 8.0%), and one or both of: dyslipidemia (LDL ≥ 130 mg/dl) or systolic hypertension (SBP ≥ 140 mmHg), irrespective of medication use. The study enrolled a total of 1,146 patients from ten clinical sites, with 575 randomized to the intervention group and 571 randomized to the usual care group. Protocol 3 Participants were recruited from 38 sub-centers in the Solan district located in the Indian state of Himachal Pradesh. All community members, aged 20 years or older and permanently residing in well-defined rural communities in the selected geographical areas, were eligible to participate. Design Protocols 1/3 The Solan Surveillance study was the rural counterpart of CARRS Surveillance study, and therefore they used similar methodology. The CARRS surveillance study was conducted in three sites: two in India (Chennai and New Delhi) and one in Pakistan (Karachi). The Solan Surveillance study was conducted in the Solan District of Himachal Pradesh, India. Recruitment occurred and data were collected via household surveys. While the primary study design for the surveillance model was cross-sectional, a cohort study design was used to follow-up the participants for three to four years subsequent to the initial cross-sectional study. Baseline surveys gathered information on demographic and socio-economic characteristics, presence of CMDs and risk factors, previous or existing target organ damage, female reproductive history, quality of life, disability, health care utilization, and quality and cost of care. Additional clinical measurements included blood pressure, pulse rate, mid-arm circumference, waist circumference, hip circumference, skinfold thickness, height, and body composition. Each surveillance study implemented a second independent cross-sectional survey several years after the first in order to estimate the trend in prevalence of CMDs and their risk factors. Outcomes of interest included anthropometric changes; incidence of new intermediate risk factors or changes in pre-existing risk factors such as dyslipidemia, hypertension, and diabetes; and morbidity and mortality associated with CMDs. Protocol 2 The CARRS Translational trial was a multi-site, individually randomized, controlled parallel group study that tested a comprehensive, multi-factorial CVD risk reduction intervention in type 2 diabetes patients attending established out-patient clinics in South Asia. The intervention strategies followed internationally accepted evidence-based CVD risk management algorithm-guidelines for individuals with diabetes, with adaptations to increase relevance to the South Asian population. The intervention utilized two major health care management strategies: (1) a web-enhanced decision-support software to store patient health records, provide automated decision-support prompts for patient management, and remind providers and participants of the guideline-recommended care processes, and (2) a non-physician care coordinator to facilitate care according to the CVD risk factor management guidelines, provide individualized follow-up according to baseline risk and compliance, empower and encourage patients to achieve management targets, and coordinate guidance from a multi-disciplinary team. The control group received the existing standard care existing at the clinical site. Potential participants were invited for two pre-randomization screening visits to assess history, anthropometry, blood pressure, heart rate, and to collect a fasting venous blood sample for glucose, HbA1c, lipid profile, creatinine, potassium, sodium, and ALT measurements. At the baseline/randomization visit, all participants underwent further assessments including a detailed history and physical examination, questionnaires (self-management, quality of life, treatment satisfaction, and cost of care), and preventive exams including urine analysis, electrocardiogram, and foot and eye examinations. Participants in the intervention group were scheduled for follow-up every three months, and participants in the control group were scheduled for yearly follow-up. Median follow-up was 28 months. The primary outcome was a sustained relative difference in those achieving multiple risk factor targets (glycemic and BP or lipid control, or both) in the intervention group, compared to the control group. Conclusions Protocol 1 Not available Protocol 2 Compared with usual care, intervention participants achieved larger reductions in HbA1c level and reported higher health related quality of life and treatment satisfaction. The multicomponent care management strategy improved achievement of diabetes care goals. Protocol 3 Not available

  Study phs004776