Clinical trial · Observational
Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification
Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept
NCT01839045CI-TRIAL-00014807unknownClinicalTrials.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 in your blood samples. The biomarker 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
- description
- ACR BI-RAD Category 3 or 4 result
Primary outcomes (2)
- measure
- Training
- timeFrame
- Baseline
- description
- Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman.
- measure
- Blinded Validation
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women from 25 years of age to below 50 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 3 weeks (21 days) of ACR BI-RADS assessment * Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2 * Samples collected under IRB approval and Informed Consent * Testing performed under IRB approval or waiver (as applicable) Exclusion Criteria: * Adults from 50 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 at any time 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.