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Gut Microbiome in Colorectal Cancer (GO)

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ClinicalTrials.gov Identifier: NCT04054908
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

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

Condition or disease
Gastrointestinal Microbiome Neoplasm, Colorectal

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gut Microbiome and Oral Fluoropyrimidine Study in Patients With Colorectal Cancer
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Recruitment rate rate (percentage of patients approached that consent to participate) [ Time Frame: Up to 2 years ]
    Feasibility and acceptability will be assessed by evaluating percentage of patients approached that consent to participate

  2. Reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens [ Time Frame: Up to 2 years ]
    Feasibility and acceptability will be assessed by evaluating reasons for nonparticipation/non-continuation of the study and adherence of submission of stool specimens

  3. Dietary Assessment Questionnaires [ Time Frame: Baseline, Day 1, Day 3, Day 7, Day 14, Day 21, at discontinuation of treatment (an average of 6 months) ]
    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

  4. Acceptability of specimens for analysis [ Time Frame: Up to 6 months ]
    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.


Secondary Outcome Measures :
  1. Change in gut microbiome diversity [ Time Frame: Up to 2 years ]
    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

  2. Change in relative abundance of following gut bacteria that occur with oral fluoropyrimidine therapy [ Time Frame: Up to 2 years ]
    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


Biospecimen Retention:   Samples With DNA
Stool samples will be collected from patient over course of the standard of care for colorectal cancer


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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-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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054908


Contacts
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Contact: Wesley Kidder, MD (877) 827-3222 Wesley.Kidder@ucsf.edu
Contact: Jennifer Luan (415) 514-6220 Jennifer.Luan@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Wesley Kidder, MD    877-827-3222    Wesley.Kidder@ucsf.edu   
Contact: Jennifer Luan    (415) 514-6220    jennifer.luan@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Wesley Kidder, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04054908     History of Changes
Other Study ID Numbers: 174527
R21CA227232 ( U.S. NIH Grant/Contract )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Gut Microbiome
Colorectal Cancer
Oral Fluoropyrimidine
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases