Clinical trial NCT06656728: CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer
Official title: Clinical Validation Of A Diagnostic Cancerend24 Screening As An Aid To The Clinician For The Diagnosis Of Cancer In Healthy Subjects Attending The ICPC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Early Detection of Cancer
Keywords: Cancer
Early detection
Venous blood sample
CancerenD24
CD24
CD11b
Malignant disease
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv Medical Center
First posted: 2024-10-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy patients who attend the Integrated Cancer Prevention Center

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the CancerenD24 Screening Assay
timeFrame: 3 years
Secondary outcomes:
measure: Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis
timeFrame: 3 years
measure: Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis
timeFrame: 3 years
measure: Sensitivity of the CancerenD24 versus any confirmed cancer
timeFrame: 12 months
measure: CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures
timeFrame: 3 months, 6 months, 9 months, 12 months
measure: Time to cancer diagnosis
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Integrated Cancer Prevention Center at the Tel Aviv Sourasky Medical Center Ichilov
Study officials:
References: