Recruiting

Correlation of Gut Microbiome with Cancer Diagnoses and Therapy Response

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Study Aim

This observational study aims to explore the connection between the composition of your gut microbiome and cancer diagnoses, as well as how it relates to your response to cancer therapy.

What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Hematologic Diseases+2

+ Hemic and Lymphatic Diseases

+ Neoplasms

From 18 to 99 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2019
See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactClinical Trials Referral Office
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 11, 2019

Actual date on which the first participant was enrolled.

This study focuses on understanding the role of gut microbiome in cancer therapy. It aims to find a connection between the gut microbiome and specific types of cancer diagnoses. The study also explores how the gut microbiome might influence the effectiveness and side effects of cancer treatments, including single or multiple therapies and stem cell transplants. This research is important as it could potentially improve cancer treatment strategies by considering the patient's gut microbiome, thereby addressing unmet needs in cancer care. Participants in this study will have their blood and stool samples collected for analysis. Their medical records will also be reviewed. The study will use a special linear multivariate regression model called MaAsLin to identify associations between microbial community abundances and clinical outcomes. Additionally, the Shogun pipeline for metagenomics data followed by analysis using Quantitative Insights Into Microbial Ecology (QIIME) 2.0 will be used to understand the gut microbiome associations with cancer diagnoses.

Official TitleRole of Gut Microbiome in Cancer Therapy
NCT05112614
Principal SponsorMayo Clinic
Study ContactClinical Trials Referral Office
Last updated: March 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

3000 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 99 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplasmsNeoplasms by SiteHematologic Neoplasms

Criteria

2 inclusion criteria required to participate
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

2 exclusion criteria prevent from participating
Unable to provide informed consent

Vulnerable adults

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Mayo Clinic in Rochester

Rochester, United StatesOpen Mayo Clinic in Rochester in Google Maps
Suspended

Mayo Clinic in Arizona

Scottsdale, United States
Suspended

Mayo Clinic in Florida

Jacksonville, United States
Recruiting
3 Study Centers