The Informed Genetics Annotated Patient Registry (iGAP)

• ClinicalTrials.gov Identifier: NCT04419896
• Recruitment Status: Enrolling by invitation
• First Posted: June 9, 2020
• Last Update Posted: April 5, 2022
• Sponsor: Medneon
• Information provided by (Responsible Party): Medneon

Study Description

Brief Summary:

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.

Condition or disease
Predisposition, Genetic

Detailed 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.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 10000 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Target Follow-Up Duration: 5 Years
• Official Title: The Informed Genetics Annotated Patient Registry: The iGAP Registry
• Actual Study Start Date: January 23, 2019
• Estimated Primary Completion Date: January 1, 2025
• Estimated Study Completion Date: January 1, 2030

Groups and Cohorts

Group/Cohort
Retrospective; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. [ Time Frame: 10 years ]
   To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. The registry will gather information on patient demographics and personal and family history, as well as test results of Germline Genetic, Genomic, and Biomarker tests.

Secondary Outcome Measures :

1. To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. [ Time Frame: 10 years ]
   To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. This registry will gather information to capture the clinical management decision making processes of the physicians, before and after receiving information from Germline Genetic, Genomic, or other Biomarker testing. Further, this registry will collect information on Patient Reported Outcomes, or patient described impacts of Germline Genetic, Genomic, or other Biomarker testing on their treatment, clinician interactions, follow-up, and mental health.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Individuals 18 years or older who meet eligibility criteria, who is screened and tested for or receives or has received Germline, Genomic, or other Biomarker Testing.

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.

Contacts and Locations

Locations

United States, California

North Valley Breast Clinic

Redding, California, United States, 96001

United States, Illinois

Advocate Good Shepherd

Barrington, Illinois, United States, 60010

United States, Michigan

Comprehensive Breast Care

Troy, Michigan, United States, 48098

United States, Tennessee

Nashville Breast Center

Nashville, Tennessee, United States, 37203

United States, Texas

Dallas Surgical

Dallas, Texas, United States, 75230

Sponsors and Collaborators

Medneon

More Information

• Responsible Party: Medneon
• ClinicalTrials.gov Identifier: NCT04419896
• Other Study ID Numbers: IGAP1000
• First Posted: June 9, 2020
• Last Update Posted: April 5, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Disease Susceptibility; Genetic Predisposition to Disease; Disease Attributes; Pathologic Processes