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NCT02647671 · ClinicalTrials.gov registry record · Phase 1
Aquamin and Prevention of Colon Cancer
A Phase 1 study of Colonic Cancer, sponsored by James Varani.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT02647671: Completed Phase 1 study of Colonic Cancer, sponsored by James Varani.
NCT02647671 is a Phase 1 study of Colonic Cancer that has completed, run by James Varani. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02647671, a Phase 1 study of Colonic Cancer, has completed, sponsored by James Varani.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the study agents and following the course of treatment, colonic biopsies will be obtained by sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal samples taken at baseline and study endpoint.
Primary Outcome
A panel of biomarkers of risk for colorectal cancer in colonic mucosal biopsies of normal appearing tissue: proliferation marker (Ki67), differentiation markers (E-cadherin, AE1/AE3 and cytokeratin \[CK 20\]), β-catenin, extracellular calcium-sensing receptor (CaSR), Caspase-3, bax and survivin assessed by quantitative immunohistology. The purpose is to compare growth, differentiation and apoptosis biomarkers, pre and post intervention.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aquamin®
- DRUG Calcium Carbonate
Study Locations (1)
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-03 |
| Phase | Phase 1 |
What the finished NCT02647671 record still lists
NCT02647671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Colonic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02647671 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT02647671 about?
NCT02647671 is a clinical study titled "Aquamin and Prevention of Colon Cancer". In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. T...
What is the current status of trial NCT02647671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2016-04. Estimated completion is 2021-03.
What conditions does trial NCT02647671 study?
This clinical trial studies the following conditions: Colonic Cancer.
What interventions are being tested in trial NCT02647671?
The interventions under investigation include: Placebo (DRUG), Aquamin® (DRUG), Calcium Carbonate (DRUG).
Who is sponsoring clinical trial NCT02647671?
This trial is sponsored by James Varani, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02647671 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
Similar trials for Colonic Cancer
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 NCT02647671's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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