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NCT02156557 · ClinicalTrials.gov registry record · Phase 1
Study of KCC Peptide Application in the Colon
A Phase 1 study of Colorectal Cancer and Inflammatory Bowel Disease (IBD), sponsored by Danielle Kim Turgeon.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT02156557: Completed Phase 1 study of Colorectal Cancer and Inflammatory Bowel Disease (IBD), sponsored by Danielle Kim Turgeon.
NCT02156557 is a Phase 1 study of Colorectal Cancer and Inflammatory Bowel Disease (IBD) that has completed, run by Danielle Kim Turgeon. The registered enrollment target is 45 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02156557, a Phase 1 study of Colorectal Cancer and Inflammatory Bowel Disease (IBD), has completed, sponsored by Danielle Kim Turgeon.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scopes to see abnormal areas that are hard to see with the naked eye. The stain or dye is "fluorescent", meaning it glows when special light is used in the colonoscopy scope. You are being asked to let us spray a peptide with a fluorescent tag onto your colon. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. The peptide we use has 7 amino acids attached to a fluorescent tag ("FIT C" or Fluoresceinisothiocyanate). FITC is used by eye doctors to examine your eyes (the yellow eye drops). We are testing this "fluorescent peptide" to see if it will stick if there are any abnormal areas. If the peptide "sticks", it will "glow" when a special light in the scope is used. In this study, we will apply the fluorescent peptide to your colon by using a spray tube that fits in the colonoscope. This is a phase IB study. This means that although we have applied the peptide to 25 people in our first research study, we still need to learn more about "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The main goal of this study is to see if the peptide "glows" well and if we can take pictures of areas that do glow. This is a research study of the peptide and our ability to see it "glow or fluoresce". Being in this study and applying the peptide won't change how our biopsies are taken or how your colonoscopy is done.
Primary Outcome
The peptide will be applied during colonoscopy to areas that appear abnormal with white light endoscopy. The peptide fluorescence will be assessed via imaging to assess specificity of binding as compared to standard of care pathology interpretation of tissue.
Conditions Studied
Interventions
- BIOLOGICAL Colon KCC Heptapeptide
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2014-06 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT02156557 record still lists
NCT02156557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Colon KCC Heptapeptide is the first listed.
NCT02156557 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02156557 about?
NCT02156557 is a clinical study titled "Study of KCC Peptide Application in the Colon". We are studying new ways to look for abnormal areas/tissues of the colon during a colonoscopy. The current scopes used for colonoscopies are very good. But if the area doesn't look different to the naked eye, then the scope can't improve on that. We are using special stains or dyes and special scope...
What is the current status of trial NCT02156557?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2014-06. Estimated completion is 2016-08.
What conditions does trial NCT02156557 study?
This clinical trial studies the following conditions: Colorectal Cancer, Inflammatory Bowel Disease (IBD), Colon Polyps.
What interventions are being tested in trial NCT02156557?
The interventions under investigation include: Colon KCC Heptapeptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT02156557?
This trial is sponsored by Danielle Kim Turgeon, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02156557 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02156557's enrollment target sits among peer trials
45 284th of 381 higher than 96 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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