Collection of Gastrointestinal Malignant and Non-malignant Human Samples

NCT03415919 | Unknown

• 1 other identifier: IRB 2017-06-0114
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To collect human tissue, blood, and fecal samples from patients suffering from Inflammatory Bowel Disease and Colorectal Cancer. The samples will be used to establish biomimetic human organ-on-a-chip technology, as well as study the role of the microbiome in the pathogenesis in human gastrointestinal diseases.

Conditions

Inflammatory Bowel Diseases; Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

• confirmation of diagnosis by pathologist

  Once tissue is collected, those samples that have a confirmed diagnosis of disease by the pathologist will be used.

  directly following procedure

Study Arms (3)

IBD patients

Patients suffering from IBD scheduled to have a biopsy by colonoscopy.

Other: no intervention will be given to patients.

CRC patients

Patients suffering from CRC scheduled to have a biopsy by colonoscopy, or surgical resection of colon.

Other: no intervention will be given to patients.

Control patients

Patients who are scheduled to have a colonoscopy for routine screening to serve as a control population.

Interventions

no intervention will be given to patients. OTHER

samples are collected at the time of a scheduled procedure that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.

CRC patients; IBD patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No special populations are targeted for accrual to this study. However, racial background may play a role in disease etiology, and a variety of races is optimal for this study to address that question. Thus, the patient's race information will be included with the sample.

You may qualify if:

• Biopsy-proven colorectal cancer scheduled to have surgical resection of primary site, at participating and approved facilities. Since it is standard clinical care to resect certain suspicious gastrointestinal masses without a pre-existing biopsy, patients who are undergoing resections for highly suspicious masses believed to be cancer, may be consented.
• Diagnosed with Inflammatory Bowel Disease (IBD) or Crohn's Disease (CD), scheduled to have biopsy and/or fecal collection.
• scheduled to have a colonoscopy as part of routine screening.
• years old.
• Ability to understand and willingness to sign a written informed consent document.

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

The University of Texas

Austin, Texas, 78712, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, diseased tissue, normal tissue, and fecal matter

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases

Study Officials

• Hyun Jung Kim, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Richard D Fleming, MD, FACS

  Associate Director for Surgical Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 30, 2018
• Study Start: July 13, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

US (1)