INTERogating Cancer for Etiology, Prevention and Therapy Navigation

Recruiting

• Conditions: Cancer; Cancer Gene Mutation; PAN Gene Mutation; Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm
• Interventions: Genetic: Pan-genomic Testing

• Registration Number: NCT06008392
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-08
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-23
• Study Start: 2023-10-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-24
• Primary Completion: 2033-09
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with a confirmed cancer diagnosis	Pan-genomic Testing	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.

Primary Outcome Measures

Name	Time	Method
Genomic sequencing of tumor tissue and blood	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.

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States