Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03343691|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment|
|Breast Cancer||Diagnostic Test: Screening Population Diagnostic Test: Breast Cancer Population|
Prospective, two arms, observational, blinded, cohort study enrolling 200 women which intended to validate the cut-off points between women with malignant tumors, benign tumors, and women without tumors (controls) and to validate the sensitivity and specificity of TM-B1 for the detection of an invasive breast tumor.
Two cohorts will be tested with TM-B1. The cohorts will differ in the percentage of women that are expected to yield a positive finding for breast cancer. Any finding in TM-B1 will not influence medical standards of care.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay|
|Actual Study Start Date :||January 22, 2018|
|Estimated Primary Completion Date :||May 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Cohort 1:Screening Population - Women presenting for routine XRM and / or breast US.
Participants will be followed for one year and the outcome of those who undergo an annual XRM / breast ultrasound will be recorded.
Diagnostic Test: Screening Population
Blood samples taken from screening population
Breast Cancer Population
Cohort 2:Breast Cancer Population - Women who were diagnosed with malignant breast tumors, as determined by biopsy, and have not yet begun any treatment for the disease.
Diagnostic Test: Breast Cancer Population
Blood samples taken from Breast Cancer population
- This study is intended to evaluate the sensitivity and specificity of the TM-B1 test compared to the Gold Standard diagnostic methods and clinical evaluations based on Digital X-Ray Mammography (XRM), and / or ultrasound, and / or MRI and / or pathology. [ Time Frame: Timepoint 1, day 1 ]the subject's blood (Groups 1 and 2)will be tested for the presence of breast cancer
- For asymptomatic women who have dense breast tissue (parenchymal density > 50% on XRM), evaluate the performance, in terms of sensitivity and specificity, of the TM-B1 test and XRM together as a breast cancer screening procedure compared to the XRM alone [ Time Frame: Timepoint one, day 1 ]The subject's blood (Groups 1 and 2) will be tested for the presence of breast cancer
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343691
|Contact: Udi Zelig, Ph.D.||firstname.lastname@example.org|
|Contact: Meir S Silver, Ph.D.||email@example.com|
|Kaplan Medical Center||Recruiting|
|Rehovot, Israel, 76100|
|Contact: Tanir Alweis, M.D. 972-50-787-4268 firstname.lastname@example.org|
|Principal Investigator: Tanir Alweis, MD|
|Principal Investigator:||Tanir N Alweis, M.D.||Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel|