The Informed Genetics Annotated Patient Registry (iGAP)

Medneon

Status: Invitation-only

Conditions: Predisposition, Genetic

Study type: Observational

Funder types: Industry

Identifiers

NCT04419896

IGAP1000

Details and patient eligibility

About

This prospective and retrospective registry will evaluate the clinical effectiveness of Germline Genetic, Genomic, and other Biomarker testing results over time in different clinical populations, in order to shape guidelines for testing, patient management, and precision therapy.

Full description

Interest and knowledge about the genetics and biology of an individual's inherited risk of disease and progression of disease is growing. Physicians are increasing using tests and technology, including Germline Genetic, Genomic, and Biomarker Testing, to provide insight into a healthy individual's risk and an affected individual's disease characteristics, in order to provide individualized clinical treatments. However, many barriers to widespread and appropriate Germline Genetic, Genomic, and Biomarker Testing persist due to complex guidelines for use, varied quality and cost, rapid advances, and adequate understanding of appropriate implementation by medical professionals. The iGAP Registry is a multi-center ongoing database designed to capture information on disease risk assessment, Germline Genetic, Genomic, and Biomarker Testing, and their utilization and impact on treatment practices and outcomes to help determine, over time, the most effective use of testing in varied patient populations and to support the increased use of precision medicine.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Retrospective Subjects:

• Men and women 18 years or older;
• Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and
• For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.

Inclusion Criteria for Prospective Subjects:

• Men and women aged 18 years or older;
• Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice);
• Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and
• Consents to be a part of the Registry.

Trial design

10,000 participants in 2 patient groups

Retrospective

Description:

Inclusion criteria for Retrospective Subjects: * Men and women 18 years or older; * Is or was a patient of a Participating Practice and was previously tested with Germline, Genomic, or other Biomarker Tests; and * For Germline Genetic Test patients, have a diagnosis of cancer or pathogenic or likely pathogenic (P/LP) result.

Prospective

Description:

Inclusion criteria for Prospective Subjects: * Men and women aged 18 years or older; * Presents consecutively to a Participating Practice and who has previously been screened and tested (i.e., is a new patient scheduled for a visit at a Participating Practice or is an existing patient who returns to a Participating Practice); * Receives or has received Germline, Genomic, or other Biomarker Testing, either through a prior healthcare provider or a Participating Practice; and * Consents to be a part of the Registry.