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NCT02052908 · ClinicalTrials.gov registry record · Phase 1
Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT02052908: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02052908 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02052908, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This randomized phase Ib trial studies the side effects and best dose of naproxen in preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of naproxen may keep cancer from forming in patients with Lynch syndrome.
Primary Outcome
Response will be defined as \>= 30% reduction in PGE2 levels. Pairwise comparisons by the two-sample t-test among the three groups (low-dose versus control, high-dose versus control, and high-dose versus low-dose) will be used. The calculation adjusts for 3 multiple comparisons using the Bonferroni correction to achieve a two-sided 5% type I error. The point estimate and the 95% exact confidence interval for the response rate will be calculated in each arm.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Naproxen
- OTHER Placebo Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2014-01-27 |
| Est. Completion | 2021-01-05 |
| Phase | Phase 1 |
What the finished NCT02052908 record still lists
NCT02052908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02052908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02052908 about?
NCT02052908 is a clinical study titled "Naproxen in Preventing DNA Mismatch Repair Deficient Colorectal Cancer in Patients With Lynch Syndrome". This randomized phase Ib trial studies the side effects and best dose of naproxen in preventing deoxyribonucleic acid (DNA) mismatch repair deficient colorectal cancer in patients with Lynch syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of naproxen may ke...
What is the current status of trial NCT02052908?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2014-01-27. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT02052908?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Naproxen (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT02052908?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02052908's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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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