Breast CancerNCT02078570
Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
An observational study of Breast Cancer, run by Provista Diagnostics, Inc at 12 sites in United States.
Trial summary
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 500 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2014to Jul 2017
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinics
Who may be able to join
- Adult women from 25 years of age to below 75 years of age
- Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
- Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
- Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
- Samples collected under IRB approval and Informed Consent
- Testing performed under IRB approval or waiver (as applicable)
- Previous approved procedures to enroll patients: breast augmentation \& cyst aspiration
Who cannot join
- Adults from 76 years of age or older and below 25 years of age
- Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
- Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
- Samples not collected under IRB approval and Informed Consent
- Testing not performed under IRB approval or waiver (as applicable)
- Prior breast cancer diagnosis.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Summit Medical Group Breast Center New Jersey
Berkeley Heights, New Jersey, 07922
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Hospital
Detroit, Michigan, 48202
Sinai Grace
Detroit, Michigan, 48235
Mercy Womens Center
Oklahoma City, Oklahoma, 73120
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic - Rochester
Rochester, Minnesota, 55095
Sutter Institute
Sacramento, California, 95816
Scripps
San Diego, California, 92103
Mayo Clinic
Scottsdale, Arizona, 85259
Avera Research Institute
Sioux Falls, South Dakota, 57105
About this study
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer ACR BI-RAD Category 3 or 4 result | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Protein Algorithmic Score (QPAS)
Part I: Establish an acceptable algorithm for the generation of a single numerical score from the combination of the 10 cancer biomarkers that comprise the dtectDx Breast v2.0 Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman
Measured: Baseline
Modified Quantitative Protein Algorithmic Score (QPAS)
Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.
Measured: 6 Months
Secondary outcomes (1)
QPAS relative to BI-RADS
Demonstrate the numerical score, collaborated via proprietary algorithm , for the dtectDx-Breast Assay v2.0 increases the likelihood of malignant breast cancer detection when used adjunctively with the assessment of BI-RADS Categories 3 and 4 compared to the assessment of BI-RADS Categories 3 and 4 alone.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2017 (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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Provista Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078570
- Sponsor's protocol ID
- dtectDx-Breast-002
- Status last verified
- Nov 2015
- First submitted
- 28 Feb 2014
- Last updated
- 30 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
- ClinicalTrials.gov ID
- NCT02078570
- Acronym / sponsor ID
- dtectDx-Breast-002
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Provista Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 5 Mar 2014 (estimated)
- 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.
The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer ACR BI-RAD Category 3 or 4 result | – | – |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinics
Key inclusion criteria (7 listed)
- Adult women from 25 years of age to below 75 years of age
- Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
- Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
- Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
- Samples collected under IRB approval and Informed Consent
Key exclusion criteria (6 listed)
- Adults from 76 years of age or older and below 25 years of age
- Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
- Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
- Samples not collected under IRB approval and Informed Consent
- Testing not performed under IRB approval or waiver (as applicable)
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
Quantitative Protein Algorithmic Score (QPAS)
Time frame: Baseline
Part I: Establish an acceptable algorithm for the generation of a single numerical score from the combination of the 10 cancer biomarkers that comprise the dtectDx Breast v2.0 Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman
Modified Quantitative Protein Algorithmic Score (QPAS)
Time frame: 6 Months
Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.
1 secondary outcome
QPAS relative to BI-RADS
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites 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 Provista Diagnostics, Inc at 12 sites 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 7 inclusion and 6 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 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Protein Algorithmic Score (QPAS) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 30 Sep 2016.