NCT02486146

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
789

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

2.5 years

First QC Date

June 19, 2015

Last Update Submit

June 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Health System

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Yu-Jui Yvonne Wan, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

July 1, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

June 21, 2017

Record last verified: 2017-06

Locations