Status:
COMPLETED
Gut Microbiome in Colorectal Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Microbiome
Neoplasm, Colorectal
Eligibility:
All Genders
18+ years
Brief Summary
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer
Detailed Description
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer (CRC). Three patient cohorts will be fol...
Eligibility Criteria
Inclusion
- The patient has histologically proven colorectal adenocarcinoma
- The patient is starting treatment with oral fluoropyrimidine therapy: CAP or TAS-102 as SOC or on a clinical trial. This also includes those patients receiving treatment in the adjuvant setting or post-metastasectomy with no evidence of disease on imaging.
- Combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, Y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted.
- Combination of CAP with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site.
- Male or female patient aged 18 years of age or older at the time of obtaining the signed and dated informed consent (no upper age limit).
- Be able to read and speak English.
- Be willing and able to provide written informed consent for the study
Exclusion
- Patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks.
- Patient has completed a course of antibiotics longer than 2 weeks in preceding six months or a course of antibiotics of any duration in the 4 weeks prior to starting oral chemotherapy. Any patient who requires treatment with antibiotics during the study may be removed at the investigator's discretion.
- Known HIV positive.
Key Trial Info
Start Date :
April 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04054908
Start Date
April 13 2018
End Date
June 30 2022
Last Update
June 14 2024
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94143