Status:
UNKNOWN
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay
Lead Sponsor:
Todos Medical, Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Brief Summary
Blood samples from a total of 200 women in two cohorts will be collected and analyzed by TM-B1 assay, which is based on TBIA (Total Biochemical Infrared Analysis) to confirm the presence of cancer. Th...
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 tumo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03343691
Start Date
January 22 2018
End Date
July 1 2019
Last Update
August 22 2018
Active Locations (1)
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1
Kaplan Medical Center
Rehovot, Israel, 76100