Collection of Gastrointestinal Malignant and Non-malignant Human Samples

NCT ID: NCT03415919

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2022-07-31

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.

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.

Conditions

Inflammatory Bowel Diseases; Colo-rectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

IBD patients

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

no intervention will be given to patients.

Intervention Type: 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

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

no intervention will be given to patients.

Intervention Type: 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.

Control patients

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

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Hyun Jung Kim

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hyun Jung Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Richard D Fleming, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Associate Director for Surgical Services

Locations

The University of Texas

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IRB 2017-06-0114

Identifier Type: -

Identifier Source: org_study_id