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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-02454 | Registry Identifier | CTRP (Clinical Trials Reporting Program) |
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Low/slow accrual
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The objective of this pilot cohort study is to investigate associations between CIN and changes in gut microbiome composition profiles.
The long-term goal of this study is to alleviate the occurrence of CIN and to improve chemotherapy treatment outcomes. The identification of associations between CIN and chemotherapy-induced changes in gut microbiome composition profiles will increase our understanding of these mechanisms that underlie CIN. An increased understanding of the underlying mechanisms will provide targets for the development of novel interventions to help alleviate CIN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with genitourinary cancers | Genitourinary medical oncologists and study coordinators will identify patients with genitourinary cancers (i.e., bladder cancer, prostate cancer, and testicular cancer) who will receive moderate to high emetogenic chemotherapy regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and Tissue | Other | Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy. Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in patient recruitment | Evaluate the feasibility of patient recruitment by using descriptive statistics to determine number of patients approached and number of patients enrolled. | Baseline, 14 days |
| Change in patient retention | Evaluate the feasibility of patient retention by using descriptive statistics to determine number of patients who completed the questionnaires at both assessments. | Baseline, 14 days |
| Change in patient specimen collection | Evaluate the feasibility of patient specimen collection by using descriptive statistics to determine number patients who provided stool samples at both assessments. | Baseline, 14 days |
| Change of the gut microbiome | Evaluate for changes in alpha and beta diversity as well as composition of the gut microbiome pre- and post-chemotherapy in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Region V3-V5 of the 16s rRNA gene will be targeted for sequencing and submitted to trimmomatic for reads trimming and quality control. | Up to 10 months |
| Associations between microbial composition functional profiles | Examine associations between microbial composition functional profiles pre- and post-chemotherapy in patients who report chemotherapy-induced nausea (CIN) after chemotherapy. Change in relative abundance of genus associated with CIN occurrence will be used to predict the function of the genus. We will use PiCrust to perform functional profiling. | Up to 10 months |
| Evaluate for differentially abundant metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a diagnosis of bladder cancer, prostate cancer, testicular cancer, cancerous sarcoma and melanoma- planning to receive moderate to highly emetogenic chemotherapy will be recruited at Mayo Clinic, Arizona, Mayo Clinic Rochester, MN and Mayo Clinic Florida.
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| Name | Affiliation | Role |
|---|---|---|
| Komal P. Singh, Ph.D., R.N. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Patients will collect stool for microbiome analysis at baseline (i.e., 3 +2 days prior to chemotherapy) and again 5-7 days following initiation of chemotherapy.
Blood samples will be collected prior to their first chemotherapy treatment, and in the second week after chemotherapy. The blood sample will be used for several assays that include gene expression, immune cell profiling, metabolite analytics, and additional omics assays.
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Evaluate for differentially abundant metabolites associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling of stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
| Up to 10 months |
| Evaluate for perturbed metabolic pathways | Evaluate for perturbed metabolic pathways associated with microbiome diversity in patients who do and do not report chemotherapy-induced nausea (CIN) after chemotherapy. Metabolomics profiling will be performed on stool samples pre- and post-chemotherapy using liquid chromatography-tandem mass spectrometry (LC-MS/MS), as well as RNA-Seq analyses. | Up to 10 months |
| Jacksonville |
| Florida |
| 32224-9980 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D011471 | Prostatic Neoplasms |
| D013736 | Testicular Neoplasms |
| D008545 | Melanoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D004700 | Endocrine System Diseases |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |
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