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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-03113 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This study is being done to identify markers and causes of cancer by analyzing patient's DNA (i.e., genetic material), RNA, plasma, tissues, or other samples that could be informative for patients with cancer. Cancer genetic testing is a series of tests that finds specific changes in cancer cells and normal cells in the body. Researchers may request to access these data as they explore how to better prevent, screen, or treat cancer. This study is also being done to create a biobank (library) of samples and information to learn more about treating cancer. Discovery of genetic variants in patients with cancer could result in opportunities for cancer prevention, earlier diagnosis or better therapy for cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Germline and Somatic Testing | Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. |
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| Group B: Germline Testing Only | Potential participants with a cancer diagnosis may be identified through the following sources: patients who will undergo or are currently undergoing clinical evaluation in practices such as, but not limited to, hematology-oncology, gastroenterology-hepatology, radiation-oncology and surgery. Participants will be enrolled in the study indefinitely unless a request to withdraw is made. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pan-genomic Testing | Genetic | Participants will be scheduled to review the study specifics, review consent and gather medical information. Once consented, samples will be collected. When the samples are received by Exact Sciences, DNA and RNA will be extracted, and sequencing will be performed. Following pan-genomic testing, participants will receive the full report with results from their care team and results will also be added to the patient's portal. If a germline finding is identified (positive pathogenic variant) the participant will also be referred for a genetic counselor visit. All results from the germline hereditary test will be reviewed by a certified genetic counselor in addition to a review of their pedigree. To help with review of any genetic research findings, the study team may request to obtain genomic data from previous genetic testing (clinical or research based). |
| Measure | Description | Time Frame |
|---|---|---|
| Genomic sequencing of tumor tissue and blood | Genomic sequencing of tumor tissue and blood will be performed to determine genomic alterations in germline and somatic cancer-related genes (SNVs, indels, CNVs from DNA and fusions from RNA) to allow the ordering hematologist/oncologist/provider to determine optimal therapy and clinical trial prospective. Researchers across the field of genomic sequencing report findings about new variations in scientific publications and collect it in databases every day. Consequently, any patient's variant of uncertain significance (VUS) result could be reclassified by emerging findings, turning previously unresolved tests into diagnostic answers. Our Translational Omics Program has a system to re-analyze a patient's exome/genome data against these new genetic findings-reviewing data and comparing it with emerging clinical genetic data to facilitate diagnoses. | Baseline; 50 years |
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Inclusion Criteria:
GROUP A: Germline and Somatic Testing
Has Mayo Clinic medical record number
Confirmed cancer diagnosis
Germline and/or somatic tumor/blood testing has been ordered by the clinical provider (or clinical delegate)
Participant aware of cancer diagnosis
Able to provide informed consent
≥ 18 years old
Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample
Ability to provide archived tissue, if somatic testing has not already been completed
GROUP B: Germline testing only:
GROUP C: Somatic tumor testing only:
Group D: Clinical standard of care germline testing via genetic counselor:
Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
Exclusion Criteria:
Note: Women who are pregnant or planning to become pregnant can take part in this study.
GROUP A: Germline and Somatic testing
GROUP B: Germline testing only
Group C: Somatic tumor testing only:
Group D: Clinical standard of care germline testing via genetic counselor:
Group E: Previous Enrollment in IRB #24-005734, 24-000609, 25-000815, 23-001689, or 24-004810:
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Participants identified internally to Mayo Clinic will be enrolled. The Mayo Clinic study team and/or subspecialty teams will identify participants that fulfill enrollment criteria. Only individuals with a confirmed cancer diagnosis who know they have cancer will be asked to participate. Group B will enroll patients who do not meet NCCN and CMS guidelines for somatic tissue testing and/or whom have had somatic tissue testing, but not germline testing previously.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Katie M. Gano, M.S. | Contact | 480-342-6082 | Gano.Katherine@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jewel J. Samadder, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
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| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Each participant will have residual/archived tissue and a new blood (or saliva, hair follicle) sample for pan-genomic testing as per standard of care testing. Additional samples (including but not limited to tissue, bone marrow, blood, urine, stool, hair follicles, etc) may be requested/collected to be used for additional genomic and other omics studies.
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| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |