- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06804395
CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
May 21, 2026 updated by: Hackensack Meridian Health
Early diagnosis of cancer allows for better treatment outcomes, higher survival rates, and lower costs of care.
It is shown that cancer monitoring for cancer in at-risk populations is a key component in early diagnosis.
The HMH Hennessey Institute for Cancer prevention and Applied Molecular Science (HICAP) is a newly founded institute, providing clinical services for cancer screening and risk assessment to the community, as well as research in cancer risk and prevention.
The CanScan registry will prospectively collect data from participants in the form of questionnaires.
The registry will also capture data that is collected as per non-research assessments, for participants who consent to participate.
The registry will facilitate better understanding of cancer risk, screening, and diagnostics.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
-
-
New Jersey
-
Totowa, New Jersey, United States, 07462
- Recruiting
- Hennessy Institute for Cancer Prevention and Applied Molecular Medicine
-
Contact:
- Lee Ifhar, MSs, CCRP
- Phone Number: 862-657-4227
- Email: Lee.ifhar@hmhn.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Individuals who are at risk for cancer or who have taken the Hennessy Institute cancer risk assessment (I.e participated in their cancer prevention program)
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
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
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.
|
|
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
|
|
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).
|
10 years from study enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elias Obeid, MD, MPH, Hackensack Meridian Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
October 1, 2034
Study Completion (Estimated)
October 1, 2034
Study Registration Dates
First Submitted
January 17, 2025
First Submitted That Met QC Criteria
January 27, 2025
First Posted (Actual)
February 3, 2025
Study Record Updates
Last Update Posted (Actual)
May 26, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Pro2024-0211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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