CancerCancerenD24NCT06656728
CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer
An observational study of Cancer and Early Detection of Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Early Detection of Cancer
- What is being tested?
- Blood-based liquid biopsy
- How many people
- 2,000 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Sep 2024to Sep 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients who attend the Integrated Cancer Prevention Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Integrated Cancer Prevention Center at the Tel Aviv Sourasky Medical Center Ichilov
Tel Aviv, 64239
Nadir Arber, Professor, +972 036973561, nadira@tlvmc.gov.il
Shiran Shapira, PhD, +972 0526842937, shiran@nano24med.com
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Early Detection of Cancer
- Being tested
- Blood-based liquid biopsy
- Keywords
- Cancer, Early detection, Venous blood sample, CancerenD24, CD24, CD11b, Malignant disease
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-based liquid biopsyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Blood-based liquid biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
Sensitivity and specificity of CancerenD24 versus the ground truth diagnosis
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
Measured: 3 years
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis
Positive and negative likelihood ratios of CancerenD24 versus the ground truth diagnosis in subjects aged 40 years and above
Measured: 3 years
Sensitivity of the CancerenD24 versus any confirmed cancer
Sensitivity of the CancerenD24 versus any confirmed cancer during the full follow-up period of 12 months in subjects aged 40 years and above
Measured: 12 months
CancerenD24 accuracy (sensitivity, specificity, PPV and NPV) measures
Measured: 3 months, 6 months, 9 months, 12 months
Time to cancer diagnosis
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start3 Sep 2024
- Primary completion4 Sep 2024
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656728
- Sponsor's protocol ID
- 0365-24-TLV
- Acronym
- CancerenD24
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06656728
- Acronym / sponsor ID
- CancerenD24 / 0365-24-TLV
- Conditions
- Cancer, Early Detection of Cancer
- Keywords
- Cancer, Early detection, Venous blood sample, CancerenD24, CD24, CD11b, Malignant disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Tel Aviv Medical Center
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Blood-based liquid biopsyPatients 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients who attend the Integrated Cancer Prevention Center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood-based liquid biopsyVenous 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 | Other | Healthy subjects |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Early Detection of Cancer, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadir Arber, Professor (+972 036973561, nadira@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the CancerenD24 Screening Assay (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.