Breast CancerTM-B1NCT03343691
Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay
An observational study of Breast Cancer, run by Todos Medical, Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Screening Population and Breast Cancer Population
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jan 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Kaplan Medical Center
Rehovot, 76100
Tanir Alweis, M.D., 972-50-787-4268, taniral@clalit.org.il
Tanir Alweis, MD
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Screening Population, Breast Cancer Population
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening PopulationDiagnostic test
Blood samples taken from screening population
Breast Cancer PopulationDiagnostic test
Blood samples taken from Breast Cancer population
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: 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. Receives: Diagnostic Test: Breast Cancer Population |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
the subject's blood (Groups 1 and 2)will be tested for the presence of breast cancer
Measured: Timepoint 1, day 1
Secondary outcomes (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
The subject's blood (Groups 1 and 2) will be tested for the presence of breast cancer
Measured: Timepoint one, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start22 Jan 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Todos Medical, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tanir N Alweis, M.D., Principal investigator, Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343691
- Sponsor's protocol ID
- IL-TM-B1-01
- Acronym
- TM-B1
- Status last verified
- Aug 2018
- First submitted
- 12 Nov 2017
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Test for Early Detection of Breast Cancer Using Todos Medical -Breast 1(TM-B1) Assay
- ClinicalTrials.gov ID
- NCT03343691
- Acronym / sponsor ID
- TM-B1 / IL-TM-B1-01
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Todos Medical, Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening Population | – | Diagnostic Test: Screening PopulationCohort 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. |
| Breast Cancer Population | – | Diagnostic Test: Breast Cancer PopulationCohort 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening PopulationBlood samples taken from screening population | Diagnostic test | Screening Population |
| Breast Cancer PopulationBlood samples taken from Breast Cancer population | Diagnostic test | Breast Cancer Population |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanir N Alweis, M.D. principal investigator
Kaplan Medical Center,Pasternak St., POB 1, Rehovot 76100, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Todos Medical, Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Udi Zelig, Ph.D. (972-55-661-6945, udi@todosmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.