Gut Microbiome in Colorectal Cancer

NCT ID: NCT04054908

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-13
• Study Completion Date: 2022-06-30

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 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

Conditions

Gastrointestinal Microbiome; Neoplasm, Colorectal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort A

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

No interventions assigned to this group

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

No interventions assigned to this group

Cohort C

Patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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-metastasectomy 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

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wesley Kidder, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R21CA227232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

174527

Identifier Type: -

Identifier Source: org_study_id