Clinical trial · Observational
Molecular Genetic Basis of Invasive Breast Cancer Risk Associated With Lobular Carcinoma in Situ
- 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 in order to better understand the biology of an abnormal lesion found in breast tissue called "lobular carcinoma in situ" (LCIS). We are interested in studying LCIS. The LCIS is not a cancer itself, but is a marker for an increased risk of cancer. We would like to look for LCIS in breast tissue removed during surgery from patients with cancer or at high risk for cancer. If LCIS is found, we will search for genes that are expressed (turned on or off) differently than in normal breast tissue. The identification of such genes would help us better understand the biology of LCIS, and its possible relationship to breast cancer.
Conditions
Conditions (3)
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 |
| Invasive Breast Cancer | Invasive Breast Carcinoma | ALIAS | 0.90 |
| Lobular Carcinoma | Breast Lobular Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tissue specimen | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- LCIS diagnosis
- description
- Patient with LCIS diagnosis
- interventionNames
- Other: Tissue specimen
Primary outcomes (1)
- measure
- To perform analyses using microarray-based gene expression profiling to determine whether a unique mRNA and microRNA gene expression profile distinguishes LCIS from normal breast epithelium and from invasive carcinoma.
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- To perform analyses using microarray-based mRNA and microRNA gene expression profiling to identify distinct molecular subtypes within LCIS.
- timeFrame
- 2 years
- measure
- Deter the nature or extent of molecular genetic alterations in LCIS as asses by mRNA & microRNA microarray canbe correl with the risk of subsequent invas breast cancer in pts with class type LCIS & those with newly described histologic variants of LCIS.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * multifocal lobular carcinoma in situ treated with prophylactic mastectomy or lumpectomy * invasive breast cancer (lobular or ductal) with coexisting lobular carcinoma in situ treated with mastectomy or lumpectomy * biopsy proven, untreated lobular carcinoma in situ * invasive lobular cancer with or without coexisting lobular carcinoma in situ treated with mastectomy or lumpectomy Exclusion Criteria: * no paraffin blocks available * no residual lobular carcinoma in situ in paraffin blocks
References
Publications (0)
Data not yet available