Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01769625 · ClinicalTrials.gov registry record · Phase 1
Changes in Biomarkers Using Prostaglandin Inhibitors
A Phase 1 study of Biomarker Change Linked to Breast Cancer, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01769625: Completed Phase 1 study of Biomarker Change Linked to Breast Cancer, sponsored by Hartford Hospital.
NCT01769625 is a Phase 1 study of Biomarker Change Linked to Breast Cancer that has completed, run by Hartford Hospital. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769625, a Phase 1 study of Biomarker Change Linked to Breast Cancer, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
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), act together 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 isola
Conditions Studied
Interventions
- DRUG placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU
Study Locations (1)
North Dakota
- University of North Dakota - Grand Forks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2009-01 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT01769625 record still lists
NCT01769625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Biomarker Change Linked to Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU is the first listed.
NCT01769625 reports a single indexed study location in North Dakota.
Frequently Asked Questions
What is clinical trial NCT01769625 about?
NCT01769625 is a clinical study titled "Changes in Biomarkers Using 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 NCT01769625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2009-01. Estimated completion is 2016-11.
What conditions does trial NCT01769625 study?
This clinical trial studies the following conditions: Biomarker Change Linked to Breast Cancer.
What interventions are being tested in trial NCT01769625?
The interventions under investigation include: placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU (DRUG).
Who is sponsoring clinical trial NCT01769625?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01769625 being conducted?
This trial has 1 study location across North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769625's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia