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NCT01111292 · ClinicalTrials.gov registry record · Phase 1

Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT01111292: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01111292 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01111292, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal cancer. Inositol is a vitamin-like substance that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

The primary objective of this study will be to evaluate the effect of myo-inositol (inositol), administered for three months, on P-β-catenin staining in areas of low grade dysplasia or in areas of prior low grade dysplasia in subjects with known colitis-induced low grade dysplasia at baseline.

Interventions

  • OTHER Placebo
  • DRUG Inositol

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2010-10
Est. Completion 2014-09
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

Why NCT01111292 stopped before completion

NCT01111292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01111292 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01111292 about?

NCT01111292 is a clinical study titled "Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia". This pilot, randomized phase I/II trial studies how well inositol works in preventing colorectal cancer in patients with abnormal cells (dysplasia) associated with inflammation of the colon (colitis). Patients with colitis-associated dysplasia may have an increased risk of developing colorectal canc...

What is the current status of trial NCT01111292?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-10. Estimated completion is 2014-09.

What interventions are being tested in trial NCT01111292?

The interventions under investigation include: Placebo (OTHER), Inositol (DRUG).

Who is sponsoring clinical trial NCT01111292?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01111292's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 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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Source: ClinicalTrials.gov NCT01111292, the US trial registry maintained by the National Library of Medicine. NCT01111292 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.