Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656728
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
CancerenD24 Screening as an Aid to the Clinician for the Diagnosis of Cancer
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CancerenD24
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
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 CD24CD11b 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None