GI Biorepository of Tissue and Bodily Fluids

The purpose of this study is to establish the working protocols for a general biorepository with the specific aim of procuring tissues and bodily fluids from the human gastrointestinal tract from a diverse range of clinical patients at the UC Davis Medical Center. The establishment of a GI-specific biorepository will support future translational endeavors within the UC Davis campus by providing laboratories with readily available GI tissue and bodily fluid samples to test newly developed hypotheses with relative ease.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases

Detailed Description

UC Davis is currently lacking a general use biorepository for GI tissues and bodily fluids. As with any translational research study, the procurement of human tissue samples can be a difficult and time- consuming process. The establishment of this biorepository will help streamline GI biospecimen collection and centralize these samples in a conveniently located space to facilitate the implementation of future unspecified translational studies.

• Study Type: Observational
• Enrollment (Actual): 789

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals to be included will be all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery. During their routinely scheduled appointment or procedure, eligible individuals will be informed of the program by the attending physician and encouraged to participate in order to establish a diverse collection of samples of GI-related pathologies and matched controls. The investigators' exclusion criteria will include minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.

Description

Inclusion Criteria:

• all consenting adults aged 18 years or older with an appointment with a healthcare professional in the Division of Gastroenterology or the Department of Surgery

Exclusion Criteria:

• minors, pregnant women, prisoners, and all other vulnerable populations who are unable to consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To build a model biorepository to streamline the biobanking process and provide centralized specimens and associated health information for translational research.	To have biospecimens available for the UC Davis IRB approved studies.	4 years

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Yu-Jui Yvonne Wan, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 27, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 575191