Actively Recruiting

Age: 40Years +
All Genders
Healthy Volunteers
ID06656728

Clinical Validation of the CancerenD24 Screening Test as an Aid for Early Cancer Diagnosis in Healthy Adults Attending the Integrated Cancer Prevention Center

Led by Tel-Aviv Sourasky Medical Center · Updated on 2024-10-24

2000

Participants Needed

1

Research Sites

156 weeks

Total Duration

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Sponsors

T

Tel-Aviv Sourasky Medical Center

Lead Sponsor

T

Tel Aviv Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the CancerenD24 index, an algorithm based on the levels of proteins CD24 and CD11b combined with clinical and laboratory data, to help detect cancer early in healthy adults. This observational study aims to assist doctors in diagnosing various cancers at an earlier stage by using this new blood-based screening tool. The study will recruit 2000 healthy male and female subjects over 40 years old without active cancer in the last five years. Participants will provide a venous blood sample during their visit to the medical center, which will be analyzed with the CancerenD24 assay. The test is designed for routine use and is not affected by fasting or the time of day when the blood is drawn. There is no treatment involved in this study, only blood collection and data gathering. The recruitment period will last 36 months. During the study, participants will complete medical exams and questionnaires covering cancer history and other health information. The main outcome measured is the performance of the CancerenD24 assay over three years, including its sensitivity, specificity, and accuracy in detecting cancer. Researchers will also monitor the time to cancer diagnosis up to three years. Participants’ usual medical care continues alongside the study involvement.

CONDITIONS

Brief Title

CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer

Who Can Participate

Age: 40Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Completion of all medical exams and questionnaires including cancer diagnoses, demographic data and other epidemiologic information
  • Willing and able to sign an informed consent
  • Age 40 years or older
Not Eligible

You will not qualify if you...

  • Age under 40 years
  • Pregnancy or breastfeeding
  • Any type of fever
  • Any cancer active at study entry or up to 5 years prior to study entry
  • Polyposis syndromes
  • Inflammatory bowel disease
  • Unwilling or unable to provide informed consent

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surveillance

Duration - Up to 3 years

Participants who undergo routine care are observed to evaluate the CancerenD24 Screening Test as an aid for early cancer diagnosis.

1 visit during routine cancer screening

Trial Site Locations

Total: 1 location

1

Integrated Cancer Prevention Center at the Tel Aviv Sourasky Medical Center Ichilov

Tel Aviv, Israel, 64239

Actively Recruiting

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Research Team

N

Nadir Arber, Professor

S

Shiran Shapira, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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