Cancer RiskNCT06804395
CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
An observational study of Cancer Risk, run by Hackensack Meridian Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Risk
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Oct 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Renata Castro, MS contact
United States1 site, 1 recruiting
- Recruiting
Hennessy Institute for Cancer Prevention and Applied Molecular Medicine
Totowa, New Jersey, 07462
Lee Ifhar, MSs, CCRP, 862-657-4227, Lee.ifhar@hmhn.org
About this study
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.
- Conditions
- Cancer Risk
- Keywords
- Cancer Prevention, Cancer Risk, Cancer Early Detection, Cancer High Risk
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years from study initiation as defined based on the date the first patient was enrolled.
Secondary outcomes (4)
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.
Measured: 10 years from study enrollment.
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.
Measured: 10 years from study enrollment
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)
Measured: 10 years from study enrollment
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).
Measured: 10 years from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2034 (estimated)
- Study completion1 Oct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elias Obeid, MD, MPH, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804395
- Sponsor's protocol ID
- Pro2024-0211
- Status last verified
- May 2026
- First submitted
- 17 Jan 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management
- ClinicalTrials.gov ID
- NCT06804395
- Acronym / sponsor ID
- Pro2024-0211
- Conditions
- Cancer Risk
- Keywords
- Cancer Prevention, Cancer Risk, Cancer Early Detection, Cancer High Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2034 (estimated)
- Study completion
- 1 Oct 2034 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Incidence of Cancer
Time frame: 10 years from study enrollment.
Genetic Risk Score (GRS)
Time frame: 10 years from study enrollment
Environmental and Lifestyle Factors
Time frame: 10 years from study enrollment
Impact of Early Detection and Prevention on Cancer Outcomes
Time frame: 10 years from study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renata Castro, MS contact
Elias Obeid, MD, MPH principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Risk, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Ifhar, MSc, CCRP (862-657-4227, Lee.ifhar@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathogenic Germline Variants (PGV) (time frame: 10 years from study initiation as defined based on the date the first patient was enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.