Cancer Risk
Conditions
Keywords
Cancer Prevention, Cancer Risk, Cancer Early Detection, Cancer High Risk
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.
Interventions
None listed
Sponsors
Hackensack Meridian Health
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTLee Ifhar, MSc, CCRP
CONTACTRenata Castro, MS
PRINCIPAL_INVESTIGATORElias Obeid, MD, MPH
Hackensack Meridian Health
Outcome results
None listed