Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03955510 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Abnormal Food Timing and Circadian Dyssynchrony in Alcohol Induced Colon Carcinogenesis

Study acronym: AFT
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion pushed from Aug 2026 to Nov 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
  2. Study completion date: May 2026 to Aug 2026v10
  3. Study completion date: Nov 30, 2025 to May 2026v9
  4. Study completion date: Nov 30, 2024 to Nov 30, 2025v8
  5. Study completion date: Nov 30, 2023 to Nov 30, 2024v7
Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: May 2023 to May 31, 2023
    • Study completion date: Nov 2023 to Nov 30, 2023
    • Start date: Jul 22, 2016 to Jul 31, 2016
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 44 to confirmed 12
    • Site details revised
    v5
  3. Primary completion date: May 2022 to May 2023
    • Study completion date: Nov 2022 to Nov 2023
    v4
  4. Primary endpoints: 1 to 3
    • Start date changed from estimate of May 2019 to Jul 22, 2016
    • Secondary endpoints: 6 to 4
    v3
  5. Primary endpoint revised
    • Secondary endpoints revised (6)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03955510
Lead Sponsor Rush University Medical Center
Conditions
(from sponsor)		 Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov