CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorTel-Aviv Sourasky Medical Center
About this trial
The purpose of the researchers is to test whether the CancerenD24 index, an algorithm based on the quantitative value of CD24, CD11b, clinical and laboratory characteristics, developed in the laboratory can help in the early detection of a malignant disease in a population of healthy subjects.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Age < 40 years
Pregnancy or breastfeeding
Any type of fever
Any cancer active at study entry or up to 5 years prior to study entry
Trial population
Healthy patients who attend the Integrated Cancer Prevention Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood-based liquid biopsy
Other interventionVenous blood sample will be taken from the patient as part of the routine blood tests taken as part of the work at the Medical Center
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Healthy subjects1 intervention
Trial outcomes
Primary outcomes
1
Evaluation of the CancerenD24 Screening Assay
To evaluate the "CancerenD24 screening assay" as an aid to physicians in diagnosing cancer in subjects aged 40 years and above
Time frame
3 yearsSecondary outcomes
1
Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis
Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above positive and negative predictive values of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above
Time frame
3 years2
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above
Time frame
3 years3
Sensitivity of the CancerenD24 versus any confirmed cancer
Sensitivity of the CancerenD24 versus any confirmed cancer during the full follow-up period of 12 months in subjects aged 40 years and above
Time frame
12 months4
CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures
Time frame
3 months, 6 months, 9 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tel-Aviv Sourasky Medical Center
Lead sponsor
Tel Aviv Medical Center
Collaborator
Source ClinicalTrials.gov