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NCT01606124 · ClinicalTrials.gov registry record · Phase 2
Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT01606124: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT01606124 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01606124, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.
Primary Outcome
The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.
Interventions
- OTHER laboratory biomarker analysis
- OTHER placebo
- OTHER questionnaire administration
- DRUG defined green tea catechin extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-05-21 |
| Phase | Phase 2 |
Why NCT01606124 stopped before completion
NCT01606124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01606124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01606124 about?
NCT01606124 is a clinical study titled "Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer". This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.
What is the current status of trial NCT01606124?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2012-06. Estimated completion is 2015-05-21.
What interventions are being tested in trial NCT01606124?
The interventions under investigation include: laboratory biomarker analysis (OTHER), placebo (OTHER), questionnaire administration (OTHER), defined green tea catechin extract (DRUG).
Who is sponsoring clinical trial NCT01606124?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01606124's enrollment target sits among peer trials
39 1459th of 2000 higher than 534 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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