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NCT Number: NCT06804395

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

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.

Recruiting

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Key information

Conditions

Cancer Risk

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hennessy Institute for Cancer Prevention and Applied Molecular Medicine

Totowa, New Jersey, 07462, United States

Location status: Recruiting

Location contact

Lee Ifhar, MSs, CCRP

CONTACT

[email protected]

862-657-4227

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Lee Ifhar, MSc, CCRP

CONTACT

[email protected]

862-657-4227

Renata Castro, MS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Feb 3, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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