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NCT03955510 · ClinicalTrials.gov registry record · NA
Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis
A NA study of Colorectal Cancer, sponsored by Rush University Medical Center.
- Active
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03955510 is a NA study of Colorectal Cancer that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 12 participants, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03955510, a NA study of Colorectal Cancer, is active but no longer recruiting, sponsored by Rush University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to study the impact of Western lifestyle, including moderate alcohol consumption and delayed eating patterns on studying individuals' susceptibility to colorectal cancer. This study aims to increase our ability to identify individuals at risk for colorectal cancer in the future. Each subject will experience four conditions (each for one week in duration with a week +/- 2 days wash-out in between): (1) "right-time eating" / no alcohol, (2) "right-time eating" / with alcohol, (3) "delayed-eating" / no alcohol, (4) "delayed-eating" / with alcohol. The order of experiments will be randomized \[concealed randomization\]. All subjects will undergo unprepped sigmoidoscopy after each week of intervention. In Aim 2, all subjects will have an option to undergo a 24h circadian assessment in the Biological Rhythms Research Lab after each week of intervention. The Investigator will assess (i) central circadian rhythms by collecting hourly salivary samples for melatonin assays and (ii) peripheral rhythm in the intestinal tract by buccal swabs once every 2h (12 time points) as well as by rectal sampling twice (every 12 hr). For Aim 3, sigmoidoscopy without sedation will be used to obtain colonic samples as the safe method compared to colonoscopy, which has some small but finite risks associated with the procedure (e.g, bleeding or perforation) as well as sedation.
Conditions Studied
Interventions
- OTHER Alcohol
- PROCEDURE Sigmoidoscopy
- OTHER Right time eating
- OTHER Delayed time eating
- PROCEDURE Optional 24h circadian assessment in the Biological Rhythms lab
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-07-31 |
| Est. Completion | 2026-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03955510
The ClinicalTrials.gov registry entry for NCT03955510 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,511-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Alcohol is the first listed.
NCT03955510 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT03955510 about?
NCT03955510 is a clinical study titled "Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis". The purpose of this study is to study the impact of Western lifestyle, including moderate alcohol consumption and delayed eating patterns on studying individuals' susceptibility to colorectal cancer. This study aims to increase our ability to identify individuals at risk for colorectal cancer in the...
What is the current status of trial NCT03955510?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2016-07-31. Estimated completion is 2026-05.
What conditions does trial NCT03955510 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT03955510?
The interventions under investigation include: Alcohol (OTHER), Sigmoidoscopy (PROCEDURE), Right time eating (OTHER), Delayed time eating (OTHER), Optional 24h circadian assessment in the Biological Rhythms lab (PROCEDURE).
Who is sponsoring clinical trial NCT03955510?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03955510 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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