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临床试验/NCT06656728
NCT06656728招募中不适用

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

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
Evaluation of the CancerenD24 Screening Assay

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Evaluation of the CancerenD24 Screening Assay

时间窗: 3 years

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

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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