An observational study in Gastrointestinal Microbiome and Neoplasm, Colorectal, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by University of California, San Francisco · Observational
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
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
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's enrollment of 50 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients treated with oral fluoropyrimidine (Capecitabine (CAP)) as part of standard of care (SOC) chemotherapy
Patients treated with Trifluridine/Tipiracil (TAS-102) including those receiving it in combination with Y-90 radioembolization as part of a clinical trial
Patients receiving CAP plus immunotherapy (pembrolizumab) and bevacizumab as part of a clinical trial.
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Up to 6 months
Change in gut microbiome diversity
Changes in the gut microbiome will be assessed by comparing the bacterial diversity present in the baseline pre-treatment stool sample to the designated initial treatment cycle midpoint for each of the three patient cohorts
Time frame: Up to 2 years
Change in relative abundance of following gut bacteria that occur with oral fluoropyrimidine therapy
Changes in relative and absolute abundance of specific bacteria from the Fusobacterium and Porphyromonas genus, and the species Bacteroides fragilis will be assessed using quantitative polymerase chain reaction (qPCR) and genus-specific primers
Time frame: Up to 2 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified data will be shared with researchers at other institutions.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco