NCT06804395

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
103mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Oct 2024Oct 2034

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2034

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

10 years

First QC Date

January 17, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

Cancer PreventionCancer RiskCancer Early DetectionCancer High Risk

Outcome Measures

Primary Outcomes (1)

  • Rate of Pathogenic Germline Variants (PGV)

    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 Outcomes (4)

  • Incidence of Cancer

    10 years from study enrollment.

  • Genetic Risk Score (GRS)

    10 years from study enrollment

  • Environmental and Lifestyle Factors

    10 years from study enrollment

  • Impact of Early Detection and Prevention on Cancer Outcomes

    10 years from study enrollment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hennessy Institute for Cancer Prevention and Applied Molecular Medicine

Totowa, New Jersey, 07462, United States

RECRUITING

Study Officials

  • Elias Obeid, MD, MPH

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lee Ifhar, MSc, CCRP

CONTACT

Renata Castro, MS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

February 3, 2025

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2034

Study Completion (Estimated)

October 1, 2034

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations