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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-10793 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (biospecimen collection, medical record review) | Patients undergo collection of blood and stool samples and have their medical records reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood and stool samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, average of 1 year |
| 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. | Through study completion, average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing cancer therapy for any underlying cancer diagnosis and patients undergoing stem cell transplant for any hematological condition
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Purna C. Kashyap, MBBS | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Active, not recruiting | Scottsdale | Arizona | 85259 | United States | |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Blood, stool
| Electronic Health Record Review | Other | Review of medical records |
|
| Mayo Clinic in Florida |
| Active, not recruiting |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
|