Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion
Wesley Kidder, MD

Description

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

Official Title

Gut Microbiome and Oral Fluoropyrimidine Study in Patients With Colorectal Cancer

Details

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 followed. Cohort A: patients treated with oral fluoropyrimidine CAP as part of standard of care (SOC) chemotherapy. Cohort B: patients treated with TAS-102 including those receiving it in combination with Y-90 radioembolization as part of a clinical trial. Cohort C: patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial. Investigators will replace participants as needed to ensure a minimum of 10 evaluable participants per cohort (or minimum total of 30 evaluable patients). Evaluable participants are defined as patients with two analyzable stool samples including a baseline sample and at least one on-treatment sample to be used in endpoint analysis

Keywords

Gastrointestinal Microbiome Neoplasm, Colorectal Gut Microbiome Colorectal Cancer Oral Fluoropyrimidine Colorectal Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  1. The patient has histologically proven colorectal adenocarcinoma
  2. 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-metastectomy with no evidence of disease on imaging.
  3. Combination of oral fluoropyrimidine with other cancer-directed therapies, including oxaliplatin, bevacizumab, Y-90 radioembolization, or immunotherapy checkpoint inhibitors, is permitted.
  4. Combination of CAP with concurrent radiation is permitted, including patients undergoing radiotherapy to a rectal primary or a metastatic site.
  5. 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).
  6. Be able to read and speak English.
  7. Be willing and able to provide written informed consent for the study

You CAN'T join if...

  1. Patient has had prior chemotherapy, biologic or immunotherapy in the previous 2 weeks.
  2. 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.
  3. Known HIV positive.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04054908
Study Type
Observational
Last Updated