Recruiting

Gut Microbiome

Sponsor:

Mayo Clinic

Code:

NCT05112614

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Electronic Health Record Review

Study Details

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Study ID

NCT05112614

Start date

Sep 11, 2019

Status verified date

Mar, 2026

Completion date

Oct 1, 2030

Anticipated

Primary completion date

Oct 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unable to provide informed consent
  • Vulnerable adults

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (biospecimen collection, medical record review)

Patients undergo collection of blood and stool samples and have their medical records reviewed.

Interventions

Biospecimen Collection

Undergo collection of blood and stool samples

Electronic Health Record Review

Review of medical records

Primary outcome measure

  • Gut microbiome associations with cancer diagnoses [ Time Frame: Through study completion, average of 1 year ]
  • Associations between microbial community abundances and clinical outcomes [ Time Frame: Through study completion, average of 1 year ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Purna C. Kashyap, MBBS

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-16.