INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)

Mayo Clinic

Status: Enrolling

Conditions: Cancer Gene Mutation; Cancer; Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm; PAN Gene Mutation

Treatments: Genetic: Pan-genomic Testing

Study type: Observational

Funder types: Other

Identifiers

NCT06008392

NCI-2024-03113 (Registry Identifier)

22-008878

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Group A: Germline and Somatic Testing

Description:

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.

Treatment:

Genetic: Pan-genomic Testing

Group B: Germline Testing Only

Description:

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.

Treatment:

Genetic: Pan-genomic Testing