Clinical trial NCT06008392: INTERogating Cancer for Etiology, Prevention and Therapy Navigation
Official title: INTERogating Cancer for Etiology, Prevention and Therapy Navigation (INTERCEPTioN)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cancer Gene Mutation
PAN Gene Mutation
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Keywords: Whole Exome Sequencing (WES)
Whole Genome Sequencing (WGS)
Genetic Testing
Genetic Counseling
Genomics
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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. 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Genomic sequencing of tumor tissue and blood
timeFrame: Baseline; 50 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jewel J. Samadder, M.D.
role: PRINCIPAL_INVESTIGATOR
References: