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

ConditionCancer Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults ( 18 and older)

Ability to provide own consent

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.

Disqualifiers

None

Trial 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)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
10 years from study initiation as defined based on the date the first patient was enrolled.

Secondary outcomes

1

Incidence of Cancer

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.

Time frame
10 years from study enrollment.
2

Genetic Risk Score (GRS)

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.

Time frame
10 years from study enrollment
3

Environmental and Lifestyle Factors

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)

Time frame
10 years from study enrollment
4

Impact of Early Detection and Prevention on Cancer Outcomes

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).

Time frame
10 years from study enrollment

Other outcomes

Sponsors and contacts

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