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NCT Number: NCT06656728

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Integrated Cancer Prevention Center at the Tel Aviv Sourasky Medical Center Ichilov

Tel Aviv, 64239, Israel

Location status: Recruiting

Location contact

Nadir Arber, Professor

CONTACT

[email protected]

+972 036973561

Nadir Arber, Professor

PRINCIPAL_INVESTIGATOR

Shiran Shapira, PhD

CONTACT

[email protected]

+972 0526842937

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Polyposis syndromes
  • Inflammatory bowel disease
  • Unwilling or unable to provide informed consent

Treatment and study plan

Blood-based liquid biopsy

Other

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

Primary outcomes

  1. Evaluation of the CancerenD24 Screening Assay

    Time frame: 3 years

    To evaluate the "CancerenD24 screening assay" as an aid to physicians in diagnosing cancer in subjects aged 40 years and above

Secondary outcomes

  1. Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis

    Time frame: 3 years

    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

  2. Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis

    Time frame: 3 years

    Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above

  3. Sensitivity of the CancerenD24 versus any confirmed cancer

    Time frame: 12 months

    Sensitivity of the CancerenD24 versus any confirmed cancer during the full follow-up period of 12 months in subjects aged 40 years and above

  4. CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures

    Time frame: 3 months, 6 months, 9 months, 12 months

  5. Time to cancer diagnosis

    Time frame: up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Nadir Arber, Professor

CONTACT

[email protected]

+972 036973561

Shiran Shapira, PhD

CONTACT

[email protected]

+972 526842937

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Collaborators

  • Tel Aviv Medical Center

Registry information

Official study 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

Acronym: CancerenD24

Important dates

Study start
2024
Primary completion
2024
Study completion
2027
First posted
Oct 24, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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