Role of Gut Microbiome in Cancer Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent
Vulnerable adults
Trial population
Patients undergoing cancer therapy for any underlying cancer diagnosis and patients undergoing stem cell transplant for any hematological condition
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and stool samples
Electronic Health Record Review
Other interventionReview of medical records
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Observational (biospecimen collection, medical record review)2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, average of 1 year2
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.
Time frame
Through study completion, average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov