Predisposition, GeneticiGAPNCT04419896
The Informed Genetics Annotated Patient Registry
An observational study of Predisposition, Genetic, run by Medneon at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Predisposition, Genetic
- How many people
- 10,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Jan 2019to 1 Jan 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Advocate Good Shepherd
Barrington, Illinois, 60010
Dallas Surgical
Dallas, Texas, 75230
Nashville Breast Center
Nashville, Tennessee, 37203
North Valley Breast Clinic
Redding, California, 96001
Comprehensive Breast Care
Troy, Michigan, 48098
About this study
Official title: The Informed Genetics Annotated Patient Registry: The iGAP Registry
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.
Read the 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.
- Conditions
- Predisposition, Genetic
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (1)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start23 Jan 2019
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Predisposition, GeneticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medneon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419896
- Sponsor's protocol ID
- IGAP1000
- Acronym
- iGAP
- Status last verified
- Apr 2022
- First submitted
- 3 Jun 2020
- Last updated
- 5 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Informed Genetics Annotated Patient Registry: The iGAP Registry
- ClinicalTrials.gov ID
- NCT04419896
- Acronym / sponsor ID
- iGAP / IGAP1000
- Conditions
- Predisposition, Genetic
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- MedneonIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
To understand Physician Decision Impact and Patient Reported Outcomes resulting from the utilization of Germline Genetic, Genomic, and Biomarker testing.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Predisposition, Genetic, run by Medneon at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To understand the utilization of Germline Genetic, Genomic, and Biomarker Testing in various clinical settings. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.