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NCT04379999 · ClinicalTrials.gov registry record · Early Phase 1
Atorvastatin ± Aspirin in Lynch Syndrome Syndrome
A Early Phase 1 study, sponsored by Fox Chase Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 43
- Enrollment target
NCT04379999: Completed Early Phase 1 study, sponsored by Fox Chase Cancer Center.
NCT04379999 is a Early Phase 1 study that has completed, run by Fox Chase Cancer Center. The registered enrollment target is 43 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04379999, a Early Phase 1 study, has completed, sponsored by Fox Chase Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.
Primary Outcome
Effect of Atorvastatin or/and Aspirin on normal colonic proliferation and apoptosis will be evaluated by comparing of immunohistochemical staining of Ki-67 and active caspase 3 using formalin-fixed paraffin-embedded biopsies collected before and at the 6 weeks of drug treatments. Number of positive cells and total number of evaluated cells will be collected for both assays. Data of cells with positive Ki-67 or active caspase 3 will be expressed as % of positive cells (# positive cells/#total eva
Interventions
- DRUG Atorvastatin 20mg
- DRUG Atorvastatin 20mg AND Aspirin 325 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2025-08-04 |
| Phase | Early Phase 1 |
What the finished NCT04379999 record still lists
NCT04379999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Atorvastatin 20mg is the first listed.
NCT04379999 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04379999 about?
NCT04379999 is a clinical study titled "Atorvastatin ± Aspirin in Lynch Syndrome Syndrome". The goal of this study is to investigate that a common cholesterol lowering agent (atorvastatin) alone or combining with a nonsteroidal anti-inflammatory drug (aspirin) would reduce the risk of colorectal cancer (CRC) in high-risk individuals with Lynch syndrome.
What is the current status of trial NCT04379999?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 43 participants. The study started on 2018-09-10. Estimated completion is 2025-08-04.
What interventions are being tested in trial NCT04379999?
The interventions under investigation include: Atorvastatin 20mg (DRUG), Atorvastatin 20mg AND Aspirin 325 mg (DRUG).
Who is sponsoring clinical trial NCT04379999?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04379999's enrollment target sits among peer trials
43 600th of 2000 higher than 1,397 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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