CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
Study Overview
Status
Status
Conditions
Conditions
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Lee Ifhar, MSc, CCRP
- Phone Number: 862-657-4227
- Email: Lee.ifhar@hmhn.org
Study Contact Backup
- Name: Renata Castro, MS
- Email: Renata.Castro@hmh.org
Study Locations
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New Jersey
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Totowa, New Jersey, United States, 07462
- Recruiting
- Hennessy Institute for Cancer Prevention and Applied Molecular Medicine
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Contact:
- Lee Ifhar, MSs, CCRP
- Phone Number: 862-657-4227
- Email: Lee.ifhar@hmhn.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- Adults ( 18 and older)
- Ability to provide own consent
Must meet at least one of the below criteria, Indicating an increased risk for cancer, any of the following:
- Family or personal history suggests a familial/hereditary disorder known or suspected of predisposition to cancer.
- Personal factors associated with an increased risk for cancer include benign breast disease, polyps, tobacco use, etc.as defined by the investigator.
- Family members of participating individuals.
- Any participant in the HICAP program regardless of cancer risk
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Pathogenic Germline Variants (PGV)
Time Frame: 10 years from study initiation as defined based on the date the first patient was enrolled.
|
Compare the number of detected PGVs as measured by a universal multi-gene panel, proactively, in a diverse community-based population of individuals.
PGV rate will be compared to NCCN genetic testing criteria at baseline, and to longitudinal cancer outcomes.
|
10 years from study initiation as defined based on the date the first patient was enrolled.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Cancer
Time Frame: 10 years from study enrollment.
|
The number of new cancer cases diagnosed in participants with specific PGV's (i.e.
"at high risk" to develop cancer) compared to those without these markers (i.e.
"low / average risk") over a period of ten years as described below.
|
10 years from study enrollment.
|
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Genetic Risk Score (GRS)
Time Frame: 10 years from study enrollment
|
GRS is a score that includes demographic data, Family history, Medical history, Epidemiologic risk factors and data stemming from SOC biospecimens analysis.
The purpose of this is to assess the association between PGV's, GRS's and the time to cancer diagnosis.
|
10 years from study enrollment
|
|
Environmental and Lifestyle Factors
Time Frame: 10 years from study enrollment
|
We will evaluate the interaction between genetic markers and environmental/lifestyle factors (e.g., smoking, diet, physical activity) on cancer risk.
This will be achieved by assessing environmental/lifestyle factors via questionnaires and correlating these with cancer incidence (Secondary Outcome 2)
|
10 years from study enrollment
|
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Impact of Early Detection and Prevention on Cancer Outcomes
Time Frame: 10 years from study enrollment
|
This study will evaluate the association between various preventive measures (e.g., regular screenings, lifestyle modifications) as reported via questionnaires and cancer outcomes (defined as overall survival, and disease-free survival).
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10 years from study enrollment
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Elias Obeid, MD, MPH, Hackensack Meridian Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- Pro2024-0211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.