NCT02960282

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2022

Completed
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

5.5 years

First QC Date

November 7, 2016

Last Update Submit

August 5, 2022

Conditions

Metastatic CarcinomaStage IV Colorectal CancerStage IVA Colorectal CancerStage IVB Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Best tumor response, defined as a complete response or a clear decrease in tumor burden

    The presence and amounts of species and their protocols will be compared to tumor response.

    Up to 2 years

Study Arms (1)

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.

Procedure: Biospecimen CollectionOther: Laboratory Biomarker Analysis

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of fecal specimens

Ancillary-Correlative (gut microbiome analysis)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (gut microbiome analysis)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort A: Patients with metastatic colorectal cancer who will begin a FOLFOX or FOLFIRI based treatment regimen as the 1st treatment for the metastatic disease. Cohort B: Patients with metastatic cancer who will begin Pembrolizumab (or another anti-PD-1 or anti-PD-L1 antibody) as single agent treatment for the metastatic disease.

You may qualify if:

  • Must be willing and able to provide fecal samples according to protocol schedule
  • 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

You may not qualify if:

  • Patients with a colostomy or any other issues that may prevent the standard methods for collection of stool are not eligible for this study
  • Patients are not enrolled or a research protocol for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Feces

MeSH Terms

Conditions

CarcinomaColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ebrahim Zandi, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

October 20, 2016

Primary Completion

April 13, 2022

Study Completion

April 13, 2022

Last Updated

August 10, 2022

Record last verified: 2022-08

Locations

US(1)