Clinical trial NCT03415919: Collection of Gastrointestinal Malignant and Non-malignant Human Samples
Official title: Collection of Gastrointestinal Malignant and Non-malignant Human Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Colo-rectal Cancer
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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.

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.

Primary outcomes:
measure: confirmation of diagnosis by pathologist
timeFrame: directly following procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas
state: Texas
Study officials:
affiliation: Assistant Professor
name: Hyun Jung Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Director for Surgical Services
name: Richard D Fleming, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: