Bio Specimen Resource (Bio bank) for Biliary Tract Disorders
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 16-000245
Sponsor Protocol Number: 16-000245
About this study
The aims of this proposal are to establish a Biorepository of specimens collected from patients with biliary tract disorders undergoing endoscopic procedures such as ERCP, which would allow development of research studies aimed at investigating molecular biomarkers and changes in the biliary composition and microbiome in patients with biliary tract diseases. Ultimately, the goal would be to identify biomarkers that would guide clinicians toward an improved ability to more effectively diagnosis or treat these conditions.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Patients with biliary tract diseases necessitating and endoscopic procedure will give written consent prior to commencement of the procedure.
The consent form will be provided to patients prior to the procedure, either during clinic visits in preparation for the endoscopic procedure, or prior to the endoscopy, while patient is receiving pre-procedure counseling and being prepped in the endoscopy suite holding area.
Will also consider enrolling hospitalized subjects who lack consent capacity and who require endoscopic therapy for biliary tract disease. These patients usually present with acute cholangitis and sepsis, thus with altered mental status or on mechanical ventilation and endotracheal intubation. Collection of biliary samples in this particular subset of patients will be very important for the study of biliary tract conditions related to infection, and thus, will be included in the study.
Pediatric participants:
Not applicable at Mayo Clinic in Florida as only adult patients are treated.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Victoria Gomez, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available