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
| Tracking Information | |||||||||
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| First Submitted Date | August 8, 2023 | ||||||||
| First Posted Date | August 23, 2023 | ||||||||
| Last Update Posted Date | October 30, 2023 | ||||||||
| Actual Study Start Date | October 12, 2023 | ||||||||
| Estimated Primary Completion Date | September 2033 (Final data collection date for primary outcome measure) | ||||||||
| Current 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.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | INTERogating Cancer for Etiology, Prevention and Therapy Navigation | ||||||||
| Official Title | INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN) | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | 50 Years | ||||||||
| Biospecimen | Retention: Samples With DNA Description: 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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| 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. | ||||||||
| Condition |
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| Intervention | 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).
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| Study Groups/Cohorts | 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.
Intervention: Genetic: Pan-genomic Testing
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 2033 | ||||||||
| Estimated Primary Completion Date | September 2033 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Individuals who have situations that would limit compliance with the study requirements:
Note: Women who are pregnant or planning to become pregnant can take part in this study. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT06008392 | ||||||||
| Other Study ID Numbers | 22-008878 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Niloy Jewel (Jewel) Samadder, Mayo Clinic | ||||||||
| Original Responsible Party | Mayo Clinic | ||||||||
| Current Study Sponsor | Mayo Clinic | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Mayo Clinic | ||||||||
| Verification Date | October 2023 | ||||||||