Role of Gut Microbiome in Cancer Therapy
2 other identifiers
observational
3,000
1 country
3
Brief Summary
This study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. The human microbiome affects the way some cancer drugs are metabolized in the human body. Information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2019
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2019
CompletedFirst Submitted
Initial submission to the registry
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
March 16, 2026
March 1, 2026
11.1 years
October 22, 2021
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Gut microbiome associations with cancer diagnoses
Will be done using Shogun pipeline for metagenomics data followed by analysis using Quantitative Insights Into Microbial Ecology (QIIME) 2.0.
Through study completion, average of 1 year
Associations between microbial community abundances and clinical outcomes
Will use a linear multivariate regression model specifically developed for microbiome data (MaAsLin, Multivariate microbial Association by Linear models.
Through study completion, average of 1 year
Study Arms (1)
Observational (biospecimen collection, medical record review)
Patients undergo collection of blood and stool samples and have their medical records reviewed.
Interventions
Undergo collection of blood and stool samples
Review of medical records
Eligibility Criteria
Patients undergoing cancer therapy for any underlying cancer diagnosis and patients undergoing stem cell transplant for any hematological condition
You may qualify if:
- Age 18-99
- Diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition
You may not qualify if:
- Unable to provide informed consent
- Vulnerable adults
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
Blood, stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Purna C. Kashyap, MBBS
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2021
First Posted
November 9, 2021
Study Start
September 11, 2019
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
March 16, 2026
Record last verified: 2026-03