- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343691
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay (TM-B1)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Udi Zelig, Ph.D.
- Phone Number: 972-55-661-6945
- Email: udi@todosmedical.com
Study Contact Backup
- Name: Meir S Silver, Ph.D.
- Phone Number: 972-54-633-5855
- Email: meir.s@todosmedical.com
Study Locations
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-
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Rehovot, Israel, 76100
- Recruiting
- Kaplan Medical Center
-
Contact:
- Tanir Alweis, M.D.
- Phone Number: 972-50-787-4268
- Email: taniral@clalit.org.il
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Principal Investigator:
- Tanir Alweis, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Cohort 1: Screening Population - Women presenting for routine XRM and / or breast US.
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.
Description
Inclusion Criteria:
Screening Population:
- Subject signed the informed consent.
- Subject is aged 25 years and older.
- Subject is presenting for routine screening or diagnostic XRM and / or breast US.
Breast Cancer Population
- Subject signed the informed consent form.
- Subject is aged 25 years and older.
- Subject was diagnosed with a malignant breast tumor, and has not yet started treatment.
Exclusion Criteria:
All Subjects:
- Subject has been diagnosed with any type of malignancy apart from breast cancer.
- Subject has been previously treated for breast cancer.
- Subject underwent any surgery within the previous year (apart from benign nevus removal).
- Subject was treated for benign tumor within the previous year (e.g. polyps or cysts).
- Subject has an active infection or inflammation from any type of infection (bacterial or viral) as determined clinically at screening.
- Subject is currently taking medications related directly to, or that can affect, the immune system such as steroids.
- Subject has any type of active autoimmune disease such as lupus or rheumatoid arthritis.
- Diagnostic drugs (e.g. contrast materials) were injected or given orally to subject within the last 7 days prior to sample collection for TM-B1 analysis.
- Subject has been taking any investigational drug which influence her health status within 30 days prior to sample collection for TM-B1 analysis.
- Subject is not feeling well at the time of blood collection for TM-B1 analysis due to suspected bacterial or viral infection or subject has symptoms such as high fever, diarrhea, headache, vomiting, dizziness etc.
- Subject is pregnant, lactating, or undergoing fertility treatment.
- Subject has participated in this study, in another cohort, and the TM-B1 test was performed.
Breast Cancer Population only:
- The subject's tumor has been surgically removed before sample collection for TM-B1 analysis.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening Population
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. |
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.
|
Blood samples taken from Breast Cancer population
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Timepoint 1, day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Timepoint one, day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tanir N Alweis, M.D., Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IL-TM-B1-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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