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Trial Title:
INTERogating Cancer for Etiology, Prevention and Therapy Navigation
NCT ID:
NCT06008392
Condition:
Cancer
Cancer Gene Mutation
PAN Gene Mutation
Conditions: Keywords:
Whole Exome Sequencing (WES)
Whole Genome Sequencing (WGS)
Genetic Testing
Genetic Counseling
Genomics
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Genetic
Intervention name:
Pan-genomic Testing
Description:
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).
Arm group label:
Participants with a confirmed cancer diagnosis
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Jewel J. Samadder, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Jeremy C. Jones, M.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Mrinal S. Patnaik, M.B.B.S.
Email:
Principal Investigator
Start date:
October 12, 2023
Completion date:
September 2033
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008392
https://www.mayo.edu/research/clinical-trials
