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

Clinical Validation Of A Diagnostic Cancerend24 Screening As An Aid To The Clinician For The Diagnosis Of Cancer In Healthy Subjects Attending The ICPC

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06656728
Acronym
CancerenD24
Enrollment
2000
Registered
2024-10-24
Start date
2024-09-03
Completion date
2027-09-30
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Early Detection of Cancer

Keywords

Cancer, Early detection, Venous blood sample, CancerenD24, CD24, CD11b, Malignant disease

Brief summary

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.

Detailed description

CD24 is a protein found naturally in the body and serves as a natural regulator of the immune system, in order to prevent its uncontrolled and disproportionate reaction. It is known that in a normal state the CD24protein is almost never expressed in healthy cells with the exception of the white blood cells of the blood cells in the adult person. In contrast, cancer and even pre-cancer cells express high levels of CD24. Sometimes this expression is associated with a more violent course of the cancer. Similarly, CD11b is another protein that is expressed on the surface of white blood cells and affects the migration of white blood cells and their penetration into the tissue. In addition, CD11b plays an important role in the tumor microenvironment and cancer progression. And it is used as a prognostic marker. The role and involvement of these proteins (CD24/CD11b) in various cellular processes, led our group of researchers to hypothesize that an algorithm based on CD24and CD11b protein expression on white blood cells can help in the early diagnosis of cancer and assist doctors in diagnosing this serious disease in its early stages. The test is intended for routine use, as an aid to doctors to identify most types of cancer in earlier stages. CancerenD24 is not affected by fasting and the time of day when the blood sample is taken. In this study, it is expected to recruit 2000 male and female subjects, who will be recruited over a period of 36 months. The experiment does not involve any treatment. During the visit to the medical center, an experienced staff member will explain the study to the patient, and after agreeing to his participation, the patient will sign an informed consent form, as is customary. After that, the same staff member will interview the patient in order to obtain demographic data and information about risk factors. After that, a venous 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. For this purpose, patients over the age of 40, without active cancer in the last 5 years, who come for a cancer screening (and sometimes other screenings) at the Integrated Cancer Prevention Center and the Medical Center will be recruited.

Interventions

OTHERBlood-based liquid biopsy

Venous 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

Sponsors

Tel Aviv Medical Center
CollaboratorOTHER
Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Completion of all medical exams and questionnaires including cancer diagnoses, demographic data and other epidemiologic information 2. Willing and able to sign an informed consent 3. Age ≥40 years

Exclusion criteria

1. Age \< 40 years 2. Pregnancy or breastfeeding 3. Any type of fever 4. Any cancer active at study entry or up to 5 years prior to study entry 5. Polyposis syndromes 6. Inflammatory bowel disease 7. Unwilling or unable to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the CancerenD24 Screening Assay3 yearsTo evaluate the CancerenD24 screening assay as an aid to physicians in diagnosing cancer in subjects aged 40 years and above

Secondary

MeasureTime frameDescription
Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis3 yearsSensitivity 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
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis3 yearsPositive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above
Sensitivity of the CancerenD24 versus any confirmed cancer12 monthsSensitivity of the CancerenD24 versus any confirmed cancer during the full follow-up period of 12 months in subjects aged 40 years and above
CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures3 months, 6 months, 9 months, 12 months
Time to cancer diagnosisup to 3 years

Countries

Israel

Contacts

Primary ContactNadir Arber, Professor
nadira@tlvmc.gov.il+972 036973561
Backup ContactShiran Shapira, PhD
shiran@nano24med.com+972 526842937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026