Data access committee for ICARUS BREAST 01
The purpose of this DAC document is to outline the principles and procedures governing access to the transcriptomic data generated from endothelial progenitor cells, or any biological origin from patients. Data Access Policy: 1) Access to this dataset is restricted and subject to approval by the DAC to ensure ethical and legal compliance. 2) The DAC reserves the right to evaluate all applications for access based on: 2.1) The scientific validity and merit of the proposed research. 2.2) The ethical considerations and adherence to data protection regulations, including GDPR. 2.3) The qualifications and affiliations of the applicants. 3) Applicants must submit a detailed research proposal, including objectives, methods, and anticipated outcomes. 4) Data usage is limited to the specified research project approved by the DAC. Any secondary use of the data requires additional approval. Confidentiality: All applicants must agree to maintain the confidentiality of the dataset. Personal identifiers have been pseudonymized to protect patient privacy. Application Process: 1) Researchers must complete the application form provided by the DAC. 2) Submit proof of ethical approval and relevant certifications for their research project. 3) Provide a signed agreement affirming adherence to the DAC's terms and conditions.
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 investigate whether the addition of antimicrobial treatments improves outcomes compared to usual care alone among patients with idiopathic pulmonary fibrosis. Background Idiopathic pulmonary fibrosis (IPF) is a chronic progressive lung disease. Lung dysbiosis, characterized by increased bacterial load and/or loss of diversity, has been reported in patients with IPF and may contribute to hospitalization and death. Clinical trials investigating other chronic disorders suggest that antimicrobial therapy favorably alters the lung microbial community. The CleanUP IPF study was initiated to determine if an antimicrobial treatment reduces respiratory hospitalization or death among patients with IPF. Participants A total of 513 participants were enrolled. 254 participants were randomized to receive antimicrobials, of those 128 were randomized to receive co-trimoxazole and 126 were randomized to receive doxycycline. 259 participants were randomized to receive usual care alone. Design CleanUP IPF was a randomized, unblinded, multicenter study. Patients were randomized to receive antimicrobials in addition to usual care or usual care alone. Antimicrobials included co-trimoxazole (trimethoprim 160 mg/sulfamethoxazole 800 mg twice daily plus folic acid 5 mg daily) or doxycycline (100 mg once daily if body weight Data collected included diffusion capacity of lungs for carbon monoxide (DLCO), forced vital capacity (FVC), and occurrence of severe adverse events. Several questionnaires were administered to assess quality of life, including the impacts of shortness of breath, fatigue, and chronic cough on participants. The primary end point was time to first nonelective respiratory hospitalization or all-cause mortality. The study was terminated early due to futility. Conclusions Among adults with idiopathic pulmonary fibrosis, the addition of co-trimoxazole or doxycycline to usual care, compared with usual care alone, did not significantly improve time to nonelective respiratory hospitalization or death. Martinez FJ, Yow E, Flaherty KR, et al. Effect of Antimicrobial Therapy on Respiratory Hospitalization or Death in Adults With Idiopathic Pulmonary Fibrosis: The CleanUP-IPF Randomized Clinical Trial. JAMA. 2021;325(18):1841-1851. doi:10.1001/jama.2021.4956
