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NCT01425476 · ClinicalTrials.gov registry record · Phase 1
Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors
A Phase 1 study, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01425476: Completed Phase 1 study, sponsored by Hartford Hospital.
NCT01425476 is a Phase 1 study that has completed, run by Hartford Hospital. The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01425476, a Phase 1 study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.
Primary Outcome
This will be measured from both baseline and completion samples. 1\. PG synthesis and metabolism, through the measurement of 15-PGDH, COX-2, and PGE2 in the breast Rationale: 1,25(OH)2D, the active form of vitamin D, has been shown in vitro to decrease PGE2 both by interfering with its production and by increasing its breakdown, leading to lower cell proliferation. Celecoxib potentiated the antiproliferative effect, allowing a much lower dose of each agent when used in combination than in isol
Interventions
- DRUG Placebo
- DRUG Celecoxib
- DRUG Cholecalciferol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT01425476 record still lists
NCT01425476 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01425476 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01425476 about?
NCT01425476 is a clinical study titled "Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors". This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease. The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination wit...
What is the current status of trial NCT01425476?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2008-07. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01425476?
The interventions under investigation include: Placebo (DRUG), Celecoxib (DRUG), Cholecalciferol (DRUG).
Who is sponsoring clinical trial NCT01425476?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01425476's enrollment target sits among peer trials
45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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