Role of Gut Microbiome in Cancer Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen Collection, Electronic Health Record Review.
- Who it may be relevant to
- Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Procedure Biospecimen Collection
Undergo collection of blood and stool samples - Other Electronic Health Record Review
Review of medical records
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05112614 · 19-003060 · NCI-2021-10793