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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
Sponsor:
Information provided by (Responsible Party):
Todos Medical, Ltd.

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. These two cohorts will yield 75 healthy women with no pathological findings, 75 women diagnosed as having benign breast tumor and 50 women diagnosed as having breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: Screening Population Diagnostic Test: Breast Cancer Population

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Collect blood from the subject in two 6 ml K2 EDTA blood collection tube (total 12 ml blood) according to standardized phlebotomy procedures.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women undergoing a breast biopsy or a screening mammography,
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Udi Zelig, Ph.D. 972-55-661-6945 udi@todosmedical.com
Contact: Meir S Silver, Ph.D. 972-54-633-5855 meir.s@todosmedical.com

Locations
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Israel
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Tanir Alweis, M.D.    972-50-787-4268    taniral@clalit.org.il   
Principal Investigator: Tanir Alweis, MD         
Sponsors and Collaborators
Todos Medical, Ltd.
Investigators
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Principal Investigator: Tanir N Alweis, M.D. Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel

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Responsible Party: Todos Medical, Ltd.
ClinicalTrials.gov Identifier: NCT03343691    
Other Study ID Numbers: IL-TM-B1-01
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases