Actively Recruiting
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
On this page
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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