Gut Microbiome in Fecal Samples From Patients With Metastatic Cancer Undergoing Chemotherapy or Immunotherapy
NCT ID: NCT02960282
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
21 participants
OBSERVATIONAL
2016-10-20
2022-04-13
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Ancillary-Correlative (gut microbiome analysis)
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 RNA gene sequencing, meta-transcriptomics analysis, and meta-proteomics analysis.
Biospecimen Collection
Undergo collection of fecal specimens
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Biospecimen Collection
Undergo collection of fecal specimens
Laboratory Biomarker Analysis
Correlative studies
Eligibility Criteria
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Inclusion Criteria
* COHORT A
* Diagnosis of metastatic colorectal cancer, where the metastatic disease has not been previously treated
* Scheduled to begin fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or folinic acid-fluorouracil-irinotecan (FOLFIRI) based chemotherapy for the advanced disease
* Must have radiologic evidence of disease
* COHORT B
* Diagnosis of metastatic cancer
* Scheduled to begin pembrolizumab or another anti-PD-1 or anti-PD-L1 antibody as single agent therapy for the treatment of the advanced disease
* Must have physical or radiologic evidence of disease
Exclusion Criteria
* Patients are not enrolled or a research protocol for treatment
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Southern California
OTHER
Responsible Party
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Principal Investigators
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Ebrahim Zandi, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2016-01584
Identifier Type: REGISTRY
Identifier Source: secondary_id
0S-16-9
Identifier Type: OTHER
Identifier Source: secondary_id
0S-16-9
Identifier Type: -
Identifier Source: org_study_id
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