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

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.

• Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis [Time frame: 3 years]
• Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis [Time frame: 3 years]
• Sensitivity of the CancerenD24 versus any confirmed cancer [Time frame: 12 months]
• CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures [Time frame: 3 months, 6 months, 9 months, 12 months]
• Time to cancer diagnosis [Time frame: up to 3 years]