Clinical trial · Observational
Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
NCT02078570CI-TRIAL-00024107unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Breast Cancer ACR BI-RAD Category 3 or 4 result
Primary outcomes (2)
- measure
- Quantitative Protein Algorithmic Score (QPAS)
- timeFrame
- Baseline
- description
- 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
- measure
- Modified Quantitative Protein Algorithmic Score (QPAS)
- timeFrame
- 6 Months
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.