INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-12

Study Completion Date

2033-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Cancer Cancer Gene Mutation PAN Gene Mutation Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Pan-genomic Testing

Intervention Type 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).

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.

Pan-genomic Testing

Intervention Type 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).

Interventions

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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).

Intervention Type GENETIC

Other Intervention Names

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Genetic testing

Eligibility Criteria

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Inclusion Criteria

GROUP A: Germline and Somatic Testing

* 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, or vice versa, if germline has already been completed may still enroll for somatic tissue testing.

GROUP B: Germline testing only:

* Has Mayo Clinic medical record number
* Confirmed cancer diagnosis
* Participant aware of cancer diagnosis
* Able to provide informed consent
* Ability to provide blood, saliva, or hair follicle sample

Exclusion Criteria

Note: Women who are pregnant or planning to become pregnant can take part in this study.

GROUP A: Germline and Somatic testing

* Individuals who have situations that would limit compliance with the study requirements
* Institutionalized (i.e. Federal Medical Prison)
* Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment, AND/OR
* Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment

GROUP B: Germline testing only

* Individuals who have situations that would limit compliance with the study requirements
* Institutionalized (i.e. Federal Medical Prison)
* Prior germline genetic testing with a 100+ multi-gene panel within the last 1 year of enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No