CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management

Recruiting

• Conditions: Cancer Risk

• Registration Number: NCT06804395
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-17
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2034-10-01
• Study Completion: 2034-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Pathogenic Germline Variants (PGV)	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Cancer	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.
Genetic Risk Score (GRS)	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.
Environmental and Lifestyle Factors	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)
Impact of Early Detection and Prevention on Cancer Outcomes	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).

Trial Locations

Locations (1)

Hennessy Institute for Cancer Prevention and Applied Molecular Medicine; 🇺🇸 Totowa, New Jersey, United States