Clinical trial NCT04054908: Gut Microbiome in Colorectal Cancer
Official title: Gut Microbiome and Oral Fluoropyrimidine Study in Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Microbiome
Neoplasm, Colorectal
Keywords: Gut Microbiome
Colorectal Cancer
Oral Fluoropyrimidine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Primary outcomes:
measure: Recruitment rate rate (percentage of patients approached that consent to participate)
timeFrame: Up to 2 years
measure: Reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens
timeFrame: Up to 2 years
measure: Dietary Assessment Questionnaires
timeFrame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, at discontinuation of treatment (an average of 6 months)
measure: Acceptability of specimens for analysis
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in gut microbiome diversity
timeFrame: Up to 2 years
measure: Change in relative abundance of following gut bacteria that occur with oral fluoropyrimidine therapy
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Wesley Kidder, MD
role: PRINCIPAL_INVESTIGATOR
References: