Clinical trial · Observational
Peptide Profiles of Women Undergoing Breast Biopsy
NCT00587821CI-TRIAL-00013166completedClinicalTrials.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)
This study is being done to learn about blood proteins. We want to see if the blood proteins in women whose biopsies show breast cancer are different from the blood proteins in women whose biopsies do not show breast cancer. The goal of this study is to develop a blood test than can help detect breast cancers when they are very small and easy to cure.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- The first 250 samples will be used as a training set and results of these breast biopsies (benign or malignant) will be used to determine the peptide profile characteristic of a diagnosis of breast cancer on biopsy.
- interventionNames
- Other: Blood draw
- label
- 2
- description
- The predictive capacity of this profile will then be prospectively assessed using the next 250 samples, which will serve as a validation set. Subjects who are candidates for enrollment on cohort B of this study (metastatic disease)
- interventionNames
- Other: Blood draw
Primary outcomes (1)
- measure
- To identify the peptide profile associated with a diagnosis of malignancy on breast biopsy.
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age ≥ or = to 18 Cohort A: Biopsy Cohort: * Referred by a healthcare provider for breast biopsy * No prior history of invasive breast cancer OR of ductal carcinoma in situ * No prior history of other malignancies within 5 years except cervical dysplasia, squamous cell carcinoma of the skin or basal cell carcinoma of the skin Cohort B: Metastatic Disease Cohort - Diagnosis of stage IV breast cancer Exclusion Criteria: * Male * Age \< 18
References
Publications (0)
Data not yet available
No reference posted for this study.