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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04419896
Other study ID # IGAP1000
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 23, 2019
Est. completion date January 1, 2030

Study information

Verified date April 2022
Source Medneon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10000
Est. completion date January 1, 2030
Est. primary completion date January 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Advocate Good Shepherd Barrington Illinois
United States Dallas Surgical Dallas Texas
United States Nashville Breast Center Nashville Tennessee
United States North Valley Breast Clinic Redding California
United States Comprehensive Breast Care Troy Michigan

Sponsors (1)

Lead Sponsor Collaborator
Medneon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. 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. 10 years
Secondary To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing. 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. 10 years
See also
  Status Clinical Trial Phase
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Completed NCT04848142 - Psychosocial Impact of Disclosing Cancer Predisposition Genetic Testing Results During Childhood
Completed NCT03982446 - Germline Mutations in Pancreatic Adenocarcinoma
Not yet recruiting NCT06450171 - Evaluation of Multi-Cancer Early Detection Testing in a High-Risk Population: The INFORM Study N/A