Early Detection of Breast Cancer

An observational study of Breast Neoplasms, run by Datar Cancer Genetics Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The TriNetra™ Breast test is intended for use as a breast cancer screening test that evaluates Circulating Tumor Cells (CTCs) associated with breast cancer. The TriNetra™Breast test should be a useful breast cancer screening option for asymptomatic women 40 years of age and older. Read more about this study

Who is it for?: Ages 40 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Neoplasms
How many people: 700 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2023to Dec 2025
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 40 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: The study population will consist of women aged 40 years and older. The target enrollment will be approximately 700 subjects, who will be divided into two non-overlapping cohorts. All subjects enrolled in the study will undergo a blood draw for TriNetraTM Breast around the time of mammography. The blood draw will have to be performed no more than 60 days after the mammography and before the breast biopsy (Cohort B).

Who may be able to join

A). For Cohort A (500 subjects are targeted to enroll)
No prior diagnosis of (any) cancer
Women aged 40 years and above at the time of mammography
Provision of signed informed consent
Capable of providing adequate health history
No co-morbidity which could impair study participation or sample collection

Show all 30Show fewer

Blood draw within sixty (60) days of performance of screening mammography
A redacted/deidentified mammography report will be available and provided
If any prior mammography was performed, the BI-RADS score should be 1 or 2 or 3
Willingness to accept follow-up contact every 6 months for up to 2 years.
Agreeable to share any future biopsy or imaging data for a maximum of 2 years from study blood draw.
B). For Cohort B (BI-RADS 4 and 5) (200 subjects are targeted to enroll)
No prior diagnosis of (any) cancer
Women aged 40 years and above at the time of mammography
Provision of signed informed consent
Current mammography indicating BI-RADS 4a,4b, 4c, or 5
Capable of providing adequate health history
No co-morbidity which could impair study participation or sample collection
Blood draw within sixty (60) days of mammography and prior to biopsy of the breast
Yet to undergo tissue diagnostic procedure for breast lesion such as fine needle, core, or excisional biopsy
A redacted/deidentified mammography report and redacted/de-identified pathology report will be available and provided
Willingness to accept follow-up contact every 6 months for up to 2 years.
Agreeable to share any future repeat biopsy or imaging data for a maximum of 2 years from study blood draw.
C). Exclusion Criteria
Prior diagnosis of (any) cancer
Subjects who are receiving any investigational agent.
Pregnant women are excluded from this study
Breastfeeding women are excluded from this study
Blood transfusion within 30 days prior to screening,
Subject has any condition that in the opinion of the investigator should preclude participation in the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Ulka Vaishampayan, MBBS,MD contact

+17349367813

vaishamu@umich.edu

United States1 site, 1 recruiting

Rogel Cancer Center
Ann Arbor, Michigan, 48109
Ulka Vaishampayan, MD, 734-936-7813, vaishamu@med.umich.edu
Stephanie K Patterson, MD FACR FSBI
Recruiting

Other trials in United States

About this study

Official title: An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above

This pivotal study is designed to provide evidence of test performance and to demonstrate its safety in the intended use population in the USA.

Read the detailed description

This prospective, case-cohort study evaluates the sensitivity and specificity of the TriNetra™-Breast test for breast cancer (adenocarcinoma) screening in women aged 40 years and older. Approximately 700 subjects will be enrolled in one of the two non-overlapping cohorts in this study. Cohort A will enroll about 500 subjects with a standard risk of breast cancer who fulfill the enrollment criteria. Cohort B will enroll approximately 200 subjects with a mammogram result of BI-RADS 4 or 5.

The results of TriNetra™ -Breast will be compared with the results of mammography. The corresponding diagnostic biopsy pathology results obtained as the standard of care will be correlated with test results to confirm the performance estimates (when indicated). Mammography will be the reference standard of evaluation of breast screening status for cohort A. Histopathology report will be the reference standard to evaluate the malignant or non-malignant clinical status for cohort B. Availability of histopathological results is mandatory for the evaluation of cohort B.

Conditions: Breast Neoplasms
Keywords: Early Detection, Mammography, Circulating Tumor Cells, Cancer Screening
Medical subject headings: Breast Neoplasms, Neoplastic Cells, Circulating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06043661
Study group	Role	What they receive
BI-RADS score 1 or 2 or 3 (Cohort A)		Subjects with a standard risk of breast cancer aged 40 years and above at the time of mammography with the BI-RADS score 1 or 2 or 3
BI-RADS score 4 or 5 (Cohort B)		Subjects aged 40 years and above at the time of mammography with the BI-RADS score 4 or 5

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
The study evaluates the clinical sensitivity and specificity of the TriNetra Breast in Mammography-Negative (BIRAD 1/2/3) and Mammography-Positive (BIRAD 4/5) Cohorts
Measured: 2 years

Secondary outcomes (4)

The Positive Predictive Values (PPV) and Negative Predictive Values (NPV)
The study evaluates the PPV and NPV of the TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
Measured: 2 years
Detection rates by TNM stage
The study evaluates the detection rates (sensitivity in %) by TNM stage for the TriNetra Breast test, using surgical pathology evaluation as a reference.
Measured: 2 years
Clinical performance in dense breast findings on mammography
The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in dense breast findings on mammography
Measured: 2 years
Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection
The study evaluates the clinical sensitivity and specificity (in %) for the TriNetra Breast test in ductal carcinoma in situ (DCIS) detection.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 2023Dec 2025

First posted21 Sep 2023
Study start9 Feb 2023
Primary completionDec 2023 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast NeoplasmsStudies 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: 700 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06043661
Sponsor's protocol ID: HUM00217725
Status last verified: Sep 2023
First submitted: 12 Sep 2023
Last updated: 21 Sep 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Crook T, Leonard R, Mokbel K, Thompson A, Michell M, Page R, Vaid A, Mehrotra R, Ranade A, Limaye S, Patil D, Akolkar D, Datta V, Fulmali P, Apurwa S, Schuster S, Srinivasan A, Datar R. Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells. Cancers (Basel). 2022 Jul 9;14(14):3341. doi: 10.3390/cancers14143341.
PubMed 35884402

Want to know more?

Ulka Vaishampayan, MBBS,MD

+17349367813

vaishamu@umich.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of a Circulating Tumor Cell-based Test (TriNetra™-Breast) for Breast Cancer Screening in Women Aged 40 and Above
ClinicalTrials.gov ID: NCT06043661
Acronym / sponsor ID: HUM00217725
Conditions: Breast Neoplasms
Keywords: Early Detection, Mammography, Circulating Tumor Cells, Cancer Screening
Study type: Observational
Recruitment status: Unknown status
Enrolment: 700 participants (estimated)
Lead sponsor: Datar Cancer Genetics IncIndustry (pharma, biotech, devices)
Study start: 9 Feb 2023 (actual)
Primary completion: Dec 2023 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 21 Sep 2023 (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.

This pivotal study is designed to provide evidence of test performance and to demonstrate its safety in the intended use population in the USA.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
BI-RADS score 1 or 2 or 3 (Cohort A)	–	–Subjects with a standard risk of breast cancer aged 40 years and above at the time of mammography with the BI-RADS score 1 or 2 or 3
BI-RADS score 4 or 5 (Cohort B)	–	–Subjects aged 40 years and above at the time of mammography with the BI-RADS score 4 or 5

Who may qualify

Ages: 40 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: The study population will consist of women aged 40 years and older. The target enrollment will be approximately 700 subjects, who will be divided into two non-overlapping cohorts. All subjects enrolled in the study will undergo a blood draw for TriNetraTM Breast around the time of mammography. The blood draw will have to be performed no more than 60 days after the mammography and before the breast biopsy (Cohort B).

Key inclusion criteria (30 listed)

A). For Cohort A (500 subjects are targeted to enroll)
No prior diagnosis of (any) cancer
Women aged 40 years and above at the time of mammography
Provision of signed informed consent
Capable of providing adequate health history

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods.
Time frame: 2 years
The study evaluates the clinical sensitivity and specificity of the TriNetra Breast in Mammography-Negative (BIRAD 1/2/3) and Mammography-Positive (BIRAD 4/5) Cohorts

4 secondary outcomes

The Positive Predictive Values (PPV) and Negative Predictive Values (NPV)
Time frame: 2 years
Detection rates by TNM stage
Time frame: 2 years
Clinical performance in dense breast findings on mammography
Time frame: 2 years
Sensitivity and specificity for ductal carcinoma in situ (DCIS) detection
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Background: PubMed 35884402Crook T, Leonard R, Mokbel K, Thompson A, Michell M, Page R, Vaid A, Mehrotra R, Ranade A, Limaye S, Patil D, Akolkar D, Datta V, Fulmali P, Apurwa S, Schuster S, Srinivasan A, Datar R. Accurate Screening for Early-Stage Breast Cancer by Detection and Profiling of Circulating Tumor Cells. Cancers (Basel). 2022 Jul 9;14(14):3341. doi: 10.3390/cancers14143341.

Related trials for Breast Neoplasms

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

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.

Ulka Vaishampayan, MBBS,MD contact

+17349367813

vaishamu@umich.edu

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 Neoplasms, run by Datar Cancer Genetics Inc at 1 site in United States.

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 30 inclusion and 0 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 21 Sep 2023. 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 United States. 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 Ulka Vaishampayan, MBBS,MD (+17349367813, vaishamu@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of this study is the sensitivity and specificity of TriNetra Breast for breast cancer screening in women 40 years and older, using mammography and histopathology confirmed diagnosis (when relevant) as the reference methods. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06043661, which also lists 1 linked publication.

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 21 Sep 2023.