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NCT01881048 · ClinicalTrials.gov registry record · Early Phase 1
Window of Opportunity Study Targeting the Inflammatory Milieu
A Early Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 42
- Enrollment target
NCT01881048: Completed Early Phase 1 study, sponsored by University of Colorado, Denver.
NCT01881048 is a Early Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 42 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01881048, a Early Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immune suppressive phenotype of PABC, and decreased metastatic potential in PABC. This unique window in breast cancer management serves as a valuable opportunity to obtain preliminary data on biomarkers and the alterations that occur when the system is troubled by a drug or other intervention which will be instrumental in designing future therapeutic or preventative strategies for larger clinical study.
Primary Outcome
Tumor cells are stained using the Ki-67 monoclonal antibody. Ki-67 is measured as a percentage of positive tumor cells. The investigator will conduct three paired t-tests comparing the percent Ki-67 at baseline to the percent Ki-67 after treatment. There will be one t-test for each arm.
Interventions
- DRUG Celecoxib
- DIETARY_SUPPLEMENT Omega-3 fatty acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2009-12-08 |
| Est. Completion | 2015-12-14 |
| Phase | Early Phase 1 |
What the finished NCT01881048 record still lists
NCT01881048 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 2 interventions - of which Celecoxib is the first listed.
NCT01881048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01881048 about?
NCT01881048 is a clinical study titled "Window of Opportunity Study Targeting the Inflammatory Milieu". The purpose of this study is to evaluate the effect of two anti-inflammatory drugs, fish oil capsules and the COX-2 inhibitor celecoxib, on pregnancy associated breast cancer (PABC). Short-term intervention with anti-inflammatory medications will demonstrate a reduction in the inflammation and immun...
What is the current status of trial NCT01881048?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 42 participants. The study started on 2009-12-08. Estimated completion is 2015-12-14.
What interventions are being tested in trial NCT01881048?
The interventions under investigation include: Celecoxib (DRUG), Omega-3 fatty acid (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01881048?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01881048's enrollment target sits among peer trials
42 605th of 2000 higher than 1,379 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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