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NCT03148015 · ClinicalTrials.gov registry record
Novel Molecular Targets for Ductal Carcinoma In Situ (DCIS)
A clinical trial, sponsored by Sentara Norfolk General Hospital.
- Completed
- Registry status
- 30
- Enrollment target
NCT03148015 is a clinical trial that has completed, run by Sentara Norfolk General Hospital. The registered enrollment target is 30 participants.
The verdict
NCT03148015 has completed, sponsored by Sentara Norfolk General Hospital.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
This project is an immunohistochemical study of archived patient breast tissue, specifically pre-invasive lesion specimens. The purpose is the discovery of novel molecular markers of pre-invasive breast lesions. These novel markers, once validated in this study, can serve as targets for individualized prevention therapy, neoadjuvant therapy for ductal carcinoma in situ (DCIS), or predictors of lesion aggressiveness. We have discovered two novel classes of DCIS molecular pathways required for the survival of DCIS neoplastic cells that will serve as the basis for the candidate molecules to be evaluated in this proposed study. The first class of DCIS molecular markers is autophagy, a cell survival mechanism that we discovered to be highly augmented in the hypoxic and nutrient deprived intraductal neoplastic cells of human DCIS (1-4). The second class of biomarker is calcium efflux that is mediated in breast cells by the calcium export pump Plasma Membrane Calcium ATPase (PMCA2) (5, 6). During normal lactation, breast epithelium pumps large concentrations of calcium into milk. In neoplastic lesions, calcium is exported by PMCA2 as a cell survival mechanism, since cells under metabolic stress accumulate calcium to a toxic level. Calcium export in DCIS may also contribute to intraductal calcifications, a hallmark of high grade DCIS and the most common marker of DCIS on mammography (7). Sentara cares for hundreds of patients per year who are diagnosed with breast pre-invasive lesions, including atypical ductal hyperplasia (ADH), ductal carcinoma in situ (DCIS), and lobular carcinoma in situ (LCIS). Sentara treats 25% of the women with breast cancer in Virginia. Coupled with information from the Sentara Cancer Registry, Dr. Hoefer or a research team member will identify eligible patients with ADH, DCIS, and/or LCIS at the time of the core biopsy diagnosis, surgical therapy, and/or upon lesion recurrence. After receiving written informed consent from the eligible patients,
Interventions
- OTHER Biomarkers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-10-01 |
| Est. Completion | 2020-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03148015
The ClinicalTrials.gov registry entry for NCT03148015 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sentara Norfolk General Hospital, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Biomarkers is the first listed.
NCT03148015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03148015 about?
NCT03148015 is a clinical study titled "Novel Molecular Targets for Ductal Carcinoma In Situ (DCIS)". This project is an immunohistochemical study of archived patient breast tissue, specifically pre-invasive lesion specimens. The purpose is the discovery of novel molecular markers of pre-invasive breast lesions. These novel markers, once validated in this study, can serve as targets for individualiz...
What is the current status of trial NCT03148015?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2016-10-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03148015?
The interventions under investigation include: Biomarkers (OTHER).
Who is sponsoring clinical trial NCT03148015?
This trial is sponsored by Sentara Norfolk General Hospital, which has 6 total clinical trials registered on ClinicalTrials.gov.
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