Gut Microbiome in Colorectal Cancer

NCT04054908 | Completed

• 2 other identifiers: 174527R21CA227232
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gastrointestinal Microbiome; Neoplasm, Colorectal

Keywords

Gut Microbiome; Colorectal Cancer; Oral Fluoropyrimidine

Outcome Measures

Primary Outcomes (4)

• Recruitment rate rate (percentage of patients approached that consent to participate)

  Feasibility and acceptability will be assessed by evaluating percentage of patients approached that consent to participate

  Up to 2 years

• Reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens

  Feasibility and acceptability will be assessed by evaluating reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens

  Up to 2 years

• Dietary Assessment Questionnaires

  Baseline questionnaires regarding bowel habits and dietary history. Patients will complete a 3-day diet record (Automated SelfAdministered 24-Hour (ASA24®) Dietary Assessment Tool or on paper) at the beginning of each treatment cycle when stool is collected. For mid-cycle or toxicity-related stool collections, patients will complete a 24-hour diet recall using the ASA24 system

  Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, at discontinuation of treatment (an average of 6 months)

• Acceptability of specimens for analysis

  Specimens collected via Fecal occult blood test (FOBT) card method will be verified as evaluable 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.

  Up to 6 months

Secondary Outcomes (2)

• Change in gut microbiome diversity

  Up to 2 years

• Change in relative abundance of following gut bacteria that occur with oral fluoropyrimidine therapy

  Up to 2 years

Study Arms (3)

Cohort A

Patients treated with oral fluoropyrimidine (Capecitabine (CAP)) as part of standard of care (SOC) chemotherapy

Cohort B

Patients treated with Trifluridine/Tipiracil (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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment will include both patients who will be taking TAS-102 and those taking CAP with or without other cancer-directed therapies, including those receiving CAP in combination with concurrent rectal radiation. Patients with colorectal cancer (CRC) expected to receive CAP or TAS-102 will be screened by the study PI, co-investigators, or study coordinators. The study coordinator may identify potential participants by various mechanisms: direct referral from a treating physician, review of schedules of medical and oncology providers at UCSF and participating sites, or phone calls from patients or referring physicians.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples will be collected from patient over course of the standard of care for colorectal cancer

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Wesley Kidder, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 13, 2019
• Study Start: April 13, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: June 14, 2024

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)