Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE) (APPRENTICE)
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|ClinicalTrials.gov Identifier: NCT03075618|
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment|
The initial study design with discussions about the different variables to be included into the investigators' prospective database started during 2014 PancreasFest held in Pittsburgh, PA in late July 2014 under the sponsorship of Collaborative Alliance for Pancreatic Education and Research (CAPER). Following this, a datasheet with variables was created, distributed through the initial participants, and further suggestions and edits were made. The investigators now plan to move ahead with a web based seminar. All previous participants, as well as new investigators/centers that have shown interest in participating throughout the world will be invited. The webinar will be chaired by Dr. Papachristou at the University of Pittsburgh and again sponsored by CAPER. The investigators plan to discuss previous experience with collaborative, multi-continent, clinical studies in pancreas research, details of IRB submission, access and technical aspects of REDCap, and review the current datasheet for any further edits needed.
Following this, each investigator will initiate the process of applying for approval to the Institutional Review Board of his/her center. University of Pittsburgh will share their accepted, ongoing PROOF protocol as a reference. Investigators/centers with active protocol approval will start enrolling patients. The investigators plan to have a Webinar every 3-4 months and/or schedule a working group meeting at DDW in May 2015 and/or EPC in June 2015 pending on attendance of these meetings by the investigators. Finally, the investigators will present all the above steps and the progress made by our working group in 2015 PancreasFest in Pittsburgh, PA.
The initial aim of this study is to develop a core of highly motivated investigators throughout the world and enroll large number of subjects into an Internet-based database. The study team plans to monitor data recording closely and prepare our first manuscript when we reach a critical number of patients. The future goal is to maintain this collaborative core and expand into designing randomized controlled trials addressing critical questions in the management of acute pancreatitis as well as applying for funding.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Acute Pancreatitis Patient Registry To Examine Novel Therapies In Clinical Experiences (APPRENTICE)|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||July 2025|
Patients with Acute Pancreatitis.
- Number of patients with persistent organ failure as assessed by their clinical course. [ Time Frame: 12 months ]Evaluation of the existing risks, predictive scores, and markers of severe disease.
- Number of patients with pancreatic necrosis as assessed by their clinical course. [ Time Frame: 12 months ]Evaluation of the existing risks, predictive scores, and markers of severe disease.
- Number of patients with persistent organ failure as assessed by their clinical course. [ Time Frame: 12 months ]Evaluation of the current management and outcomes of acute pancreatitis around the world.
- Number of patients with pancreatic necrosis as assessed by their clinical course. [ Time Frame: 12 months ]Evaluation of the current management and outcomes of acute pancreatitis around the world.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075618
|Contact: Emily C Baehr, BAemail@example.com|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Emily C Baehr, BA 412-648-5652 firstname.lastname@example.org|
|Principal Investigator: Georgios I Papachristou, MD|
|Principal Investigator:||Georgios I Papachristou, MD||University of Pittsburgh|