Collection of Gastrointestinal Malignant and Non-malignant Human Samples

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.

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.

- 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.