Patient case: 52-year-old male with Colon cancer. Genetic variant: KRAS (G13D), BRAF (V600E). Other conditions: Type II Diabetes, Hypertension.

Clinical trial: Acquisition of Blood and Tumor Tissue Samples From Patients With Gastrointestinal Cancer

Summary: Background:
  - Gastrointestinal cancers can occur in the throat, stomach, gallbladder, liver, pancreas, and colon. Researchers are interested in evaluating how active the immune system is in trying to fight the cancer by studying blood and tumor tissue donated from individuals who have been diagnosed with gastrointestinal cancers.
  Objectives:
  - To collect blood and tumor samples from individuals who have been diagnosed with gastrointestinal cancers in order to study the immune system s response to the cancer.
  Eligibility:
  - Individuals at least 18 years of age who have been diagnosed with throat, stomach, gallbladder, liver, pancreatic, or colon cancer, and are scheduled to be treated at the National Institutes of Health.
  Design:
  -  The study will require at least one but no more than four visits to the National Institutes of Health Clinical Center.
  -  Participants will be screened with a physical examination and medical history, and will provide a baseline blood sample for study.
  -  Participants will provide additional blood samples 2 and 4 months after the baseline sample, as well as a final sample at the completion of the treatment protocol.
  -  Participants will provide tumor tissue samples only if they undergo a surgical procedure related to the treatment for their gastrointestinal cancer.
  -  No treatment will be provided as part of this protocol.

Detailed description: BACKGROUND:
  -  Numerous recent therapeutic advances have changed standard treatment options for patients with GI cancer. These include newer chemotherapeutic agents in addition to established proof of principle for anti-angiogenic agents. The burden of GI cancers is reflected by the presence of three GI cancer types in the top five causes of cancer mortality. Over 58,000 deaths yearly can be attributed to GI cancer.
  -  While immune-based therapies in GI cancers are experimental at the current time, a gathering body of literature is suggestive of an enormous potential, either alone, or most likely in combination with standard chemotherapy.
  -  Before immunotherapy can be combined with non-immune based treatment options we first need to investigate the effects of non-immune based therapies on immune responses (especially immune-evasive mechanisms) with cancer.
  -  Commensal gut microbiota play an important role in colonic inflammation and colon cancer. The human gut flora consists of approximately 100 trillion microbial cells, which their disruption leads to many types of diseases including inflammatory bowel disease and colorectal cancer. Recent studies have shown that colon cancer patients as well other patients with gastrointestinal cancers have an altered gut flora when compared to healthy controls. As an example, intestinal microbiome has been shown to contribute to the start and progression of certain kinds of liver diseases such as NAFLD as well as end-stage liver diseases1-3 Therefore, it is important to investigate further as to how the gut affects the patient s response to chemotherapy, other types of cancer therapy and to tumor growth in general.
  OBJECTIVES:
  -  To collect blood and/or tumor samples, including pleural and peritoneal fluid, from patients with gastrointestinal (GI) cancers being reviewed by Medical Oncology Branch and to perform an analysis of immune subsets with regard to their function and how they modulate with therapy. Also to collect from patients with non-GI cancers for comparison.
  -  To identify new immune suppressor mechanisms
  -  To collect blood samples from both patients with GI cancer and also age-matched healthy
  controls for exploratory quantitative and qualitative analysis of circulating tumor cells (CTC assay) and to sequence 250 genes in circulating tumor cells and PBMC.
  - To study changes in the microbiome over time in patients with GI cancers and correlate such changes with outcome and/or other immune parameters.
  ELIGIBILITY:
  -  Patients undergoing evaluation for participation in NCI treatment protocols in the NCI intramural program with diagnosis of cancer.
  -  18 year of age or older.
  DESIGN:
  -  Blood and/or tumor samples may be collected from consenting subjects at the initial visit and/or at follow-up visits.
  -  Analysis of immune function will be performed both at baseline, and at subsequent visits, if they have follow up at NIH, at up to two additional time points when the patient returns for follow-up, and end of therapy.
  -  Blood will also be obtained from patients and healthy controls for CTC analysis.
  -  Stool samples will be obtained to determine the intestinal microbiome.

Eligibility: -  INCLUSION CRITERIA:
  -  Patients 18 years of age and older
  -  Patients with a diagnosis of cancer
  -  Patients must be willing to provide informed consent
  EXCLUSION CRITERIA:

Relevance to patient case: not relevant