Collection of Gastrointestinal Malignant and Non-malignant Human Samples

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Inflammatory Bowel Diseases; Colo-rectal Cancer
• Intervention / Treatment: Other: no intervention will be given to patients.

Detailed Description

The purpose of the proposed research is to collect tissue, blood and fecal samples from patients undergoing standard of care for their gastrointestinal disease, including Inflammatory Bowel Disease (IBD), and Colorectal Cancer (CRC). Tissue and blood samples will be obtained during procedures that are part of normal treatment, including blood and fecal collection, surgical resection, and biopsy collection. Samples will be obtained from consenting patients at Seton Dell Medical Center at the University of Texas (SDMCUT), or other relevant facilities (see section 6.i below), and only tissue not required for histopathological analysis will be collected. Initially, the focus will be on IBD, and CRC, where there are extensive previous studies to draw from.

The collected samples of the proposed study will be used to establish biomimetic human organ-on-a-chip platforms by leveraging microfluidic tissue culture technology. Another focus of the research will be study the human intestinal microbiome that is highly associated with the pathogenesis of human gastrointestinal diseases. The investigators have developed the microchip technology to mimic the structure and physiological function of human intestine by integrating tools developed in a microfluidic device, tissue engineering, and clinical microbiology, using intestinal cell lines. To recreate more reliable intestinal disease models and to further investigate the host-gut microbiome interactions in these experimental platforms, the investigators are transitioning to use human clinical samples. The investigators will use tissue biopsies to culture human intestinal cells including epithelium, endothelium, connective tissues on-chip. Blood samples will also obtained to isolate peripheral blood mononuclear cells (PBMC) that represent mixed population of white blood cells (WBC). Isolated WBCs will be co-cultured with intestinal cells. Any potential application of microbiome-related therapies such as fecal microbiota transplantation (FMT) will also be further investigated.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • The University Of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

  • 18 years old.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• The study will not exclude potential subjects from participation on the basis of ethnic origin or gender. Subjects recruited will include men, women, and all ethnic origins, provided they meet all inclusion criteria listed above.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IBD patients; Patients suffering from IBD scheduled to have a biopsy by colonoscopy.	Other: no intervention will be given to patients.; 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; Patients suffering from CRC scheduled to have a biopsy by colonoscopy, or surgical resection of colon.	Other: no intervention will be given to patients.; 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.
Control patients; Patients who are scheduled to have a colonoscopy for routine screening to serve as a control population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Hyun Jung Kim, PhD, Assistant professor; Principal Investigator: Richard D Fleming, MD, FACS, Associate Director for Surgical Services

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: IRB 2017-06-0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no protected health information will be shared with other researchers. Experimental data, and samples obtained during this study may be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No