Clinical trial · Observational
Autoantibodies in Breast Cancer Detection
NCT03623945CI-TRIAL-00083584ABCDterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed to enrollment and data and specimen collection due to lack of funding.
Summary
Brief summary (as posted)
Prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. We are no longer enrolling women who had normal Screening mammograms.
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 |
|---|---|---|---|
| Collection of blood | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Cohort A
- description
- Patients who have recently had an abnormal mammogram, followed by a breast biopsy and an initial diagnosis of Stage I, II, III or IV invasive breast cancer, will be invited to participate. Stage I, II and III participants will be further categorized into high-risk and low-risk. For the purposes of this study, participants with at least one of the following will be considered high-risk; any triple negative cancer, any grade III cancer, lymph node involvement, tumor greater than 2cm, or any patient receiving cytotoxic chemotherapy.
- interventionNames
- Other: Collection of blood
- label
- Cohort B
- description
- Patients who have recently had an abnormal mammogram, followed by a breast biopsy and diagnosed with a benign but high-risk pathology, will be invited to participate. This includes, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), flat epithelia atypia or phylloides. Accrual to Cohort B is complete.
- interventionNames
- Other: Collection of blood
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inclusion Criteria: All Cohorts: * Women age 18 and older * Understand and provide informed consent and HIPAA Authorization prior to initiation of any study-specific procedures Cohort A: * Recent abnormal mammogram followed by a breast biopsy * Initial diagnosis of Stage I, II, III or IV invasive breast cancer Cohort B: * Recent abnormal mammogram followed by a breast biopsy * Diagnosed benign breast tumor with high-risk pathology. This would include, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (LCIS), ductal carcinoma in situ (DCIS), flat epithelia atypia and phylloides Cohort C: * Recent abnormal mammogram followed by a breast biopsy * Diagnosed benign breast tumor. This would include, but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and Pseudoangiomatous stromal hyperplasia (PASH) Cohort D: • Normal screening mammogram within the last 6 months Exclusion Criteria: * All Cohorts: * Men. * Unable or unwilling to give written informed consent Cohort A: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (DCIS) and cervical carcinoma in situ. Cohort B: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. Cohort C: • History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. Cohort D: * History of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. * History of or current autoimmune disease including but not limited to Sjogrens Syndrome, Systemic Sclerosis (SSc), Scleroderma (Scl) and Dermatomyositis, Systemic Lupus Erythematosus, Multiple Sclerosis, Type I Diabetes, Rheumatoid Arthritis * History of abnormal mammogram
References
Publications (0)
Data not yet available
No reference posted for this study.