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

NCT06656728 | Recruiting DMC

• 1 other identifier: 0365-24-TLV
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Early Detection of Cancer

Keywords

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

Outcome Measures

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

  3 years

Secondary Outcomes (5)

• Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis

  3 years

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

  3 years

• Sensitivity of the CancerenD24 versus any confirmed cancer

  12 months

• CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures

  3 months, 6 months, 9 months, 12 months

• Time to cancer diagnosis

  up to 3 years

Study Arms (1)

Healthy subjects

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

Other: Blood-based liquid biopsy

Interventions

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

Healthy subjects

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy patients who attend the Integrated Cancer Prevention Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Tel Aviv Medical Center: collaborator

Study Sites (1)

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

Tel Aviv, 64239, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Nadir Arber, Professor

CONTACT

+972 036973561; nadira@tlvmc.gov.il

Shiran Shapira, PhD

CONTACT

+972 526842937; shiran@nano24med.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: September 3, 2024
• Primary Completion: September 4, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)