Role of Gut Microbiome in Cancer Therapy

NCT ID: NCT05112614

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-11

Study Completion Date

2030-10-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVE:

I. To correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.

OUTLINE:

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

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (biospecimen collection, medical record review)

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

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood and stool samples

Electronic Health Record Review

Intervention Type OTHER

Review of medical records

Interventions

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Biospecimen Collection

Undergo collection of blood and stool samples

Intervention Type PROCEDURE

Electronic Health Record Review

Review of medical records

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Purna C. Kashyap, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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NCI-2021-10793

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-003060

Identifier Type: -

Identifier Source: org_study_id

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