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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients | Patients suffering from IBD scheduled to have a biopsy by colonoscopy. |
| |
| CRC patients | Patients suffering from CRC scheduled to have a biopsy by colonoscopy, or surgical resection of colon. |
| |
| Control patients | Patients who are scheduled to have a colonoscopy for routine screening to serve as a control population. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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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.
Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Jung Kim, PhD | Assistant Professor | Principal Investigator |
| Richard D Fleming, MD, FACS | Associate Director for Surgical Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas | Austin | Texas | 78712 | United States |
no protected health information will be shared with other researchers. Experimental data, and samples obtained during this study may be shared with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2018 | Aug 23, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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blood, diseased tissue, normal tissue, and fecal matter
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D003108 | Colonic Diseases |