INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06008392 |
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Recruitment Status :
Recruiting
First Posted : August 23, 2023
Last Update Posted : October 30, 2023
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Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
Niloy Jewel (Jewel) Samadder, Mayo Clinic
- Study Details
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Brief Summary:
The purpose of this study is to evaluate the integration of cancer pan-genetic testing into a cancer clinical practice and understand both its use and effect in "real world" practice conditions.
| Condition or disease | Intervention/treatment |
|---|---|
| Cancer Cancer Gene Mutation PAN Gene Mutation | Genetic: Pan-genomic Testing |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 50 Years |
| Official Title: | INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN) |
| Actual Study Start Date : | October 12, 2023 |
| Estimated Primary Completion Date : | September 2033 |
| Estimated Study Completion Date : | September 2033 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Participants with a confirmed cancer diagnosis
Potential participants 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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Genetic: Pan-genomic Testing
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). |
Primary Outcome Measures :
- Genomic sequencing of tumor tissue and blood [ Time Frame: Baseline; 50 years ]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.
Biospecimen Retention: Samples With DNA
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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Has Mayo Clinic medical record number,
- Confirmed cancer diagnosis which is either recurrent, relapsed, refractory, metastatic, or advanced,
- Participant aware of cancer diagnosis,
- Able to provide informed consent,
- Ability to provide blood, saliva, bone marrow aspirate or hair follicle sample,
- Ability to provide archived tissue, Note: if tissue unavailable participant may still enroll onto the study for the germline collection.
Exclusion Criteria:
Individuals who have situations that would limit compliance with the study requirements:
- Institutionalized (i.e. Federal Medical Prison),
- Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment, AND/OR
- Prior somatic (250+ gene) testing within the prior 3 months of enrollment
Note: Women who are pregnant or planning to become pregnant can take part in this study.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008392
Contacts
| Contact: Clinical Trials Referral Office | 855-776-0015 | mayocliniccancerstudies@mayo.edu | |
| Contact: Katie M. Gano, M.S. | 480-342-6082 | Gano.Katherine@mayo.edu |
Locations
| United States, Arizona | |
| Mayo Clinic in Arizona | Not yet recruiting |
| Scottsdale, Arizona, United States, 85259 | |
| Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
| Principal Investigator: Jewel J. Samadder, M.D. | |
| United States, Florida | |
| Mayo Clinic in Florida | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
| Principal Investigator: Jeremy C. Jones, M.D. | |
| United States, Minnesota | |
| Mayo Clinic in Rochester | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Referral Office 855-776-0015 mayocliniccancerstudies@mayo.edu | |
| Principal Investigator: Mrinal S. Patnaik, M.B.B.S. | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Jewel J. Samadder, M.D. | Mayo Clinic |
| Responsible Party: | Niloy Jewel (Jewel) Samadder, Principal Investigator, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT06008392 |
| Other Study ID Numbers: |
22-008878 |
| First Posted: | August 23, 2023 Key Record Dates |
| Last Update Posted: | October 30, 2023 |
| Last Verified: | October 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Niloy Jewel (Jewel) Samadder, Mayo Clinic:
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Whole Exome Sequencing (WES) Whole Genome Sequencing (WGS) Genetic Testing Genetic Counseling Genomics |