Trials / Terminated
TerminatedNCT02960282
Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy
The Role of Microbiome in Cancer Therapy
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 21 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This research trial studies the gut microbiome in fecal samples from patients with cancer that has spread to other parts of the body who are undergoing chemotherapy or immunotherapy. Studying samples of feces from patients with metastatic cancer in the laboratory may help doctors learn if the make-up of the gut microbiome has a positive or negative influence to a patient's response to chemotherapy or immunotherapy.
Detailed description
PRIMARY OBJECTIVES: I. To quantitatively determine the composition of the microflora and their gene and protein expression levels in patients with metastatic colorectal cancer being treated with fluorouracil (5-FU) based chemotherapy, or anti-PD1 immunotherapy. SECONDARY OBJECTIVES: I. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with response to chemotherapy or immunotherapy. II. Compare the changes in species composition and in the metabolic activities (as determined in the primary objective) with toxicities and side effects resulting with chemotherapy or immunotherapy. OUTLINE: Patients undergo collection of fecal specimens at baseline, prior to start of each course of chemotherapy or immunotherapy, at the end of weeks 2, 4, 6, and 8, at the end of course 3 and courses thereafter of chemotherapy or immunotherapy, and at the time of disease progression or going off-treatment. Fecal specimens are analyzed via 16S ribosomal ribonucleic acid (RNA) gene sequencing, meta-transcriptomics analysis, and meta-proteomics analysis.
Conditions
- Metastatic Carcinoma
- Stage IV Colorectal Cancer
- Stage IVA Colorectal Cancer
- Stage IVB Colorectal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo collection of fecal specimens |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2016-10-20
- Primary completion
- 2022-04-13
- Completion
- 2022-04-13
- First posted
- 2016-11-09
- Last updated
- 2022-08-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02960282. Inclusion in this directory is not an endorsement.