Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active NA study of Colorectal Cancer, sponsored by Rush University Medical Center.
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 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sigmoid mucosal biopsy specimens are collected at baseline and at the end of each intervention week. Using gene expression analysis (RNA seq), impact of our intervention on sigmoid mucosal samples, with regard to the mucosal immune response will be assessed. This will be assessed by % change in immune expression. Tissue staining will be used to measure the effect of our interventions on markers of colonic neoplastic process including epithelial proliferation and apoptosis. The effect will be as
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 |
What the registry record for NCT03955510 still lists
NCT03955510 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Colorectal 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 NCT03955510's enrollment target sits among peer trials
12 367th of 381 higher than 12 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans
RECRUITING · NA
-
Precise Oncology Interventions in Nutrition and Training (OnPoint)
RECRUITING · NA
-
Resistance Exercise and Creatine in Colorectal Cancer
RECRUITING · NA
-
Optimal Perioperative Pain Control in Minimally Invasive Abdominal Cancer Surgery
RECRUITING · NA
-
Ultrasound and Photoacoustic Imaging for Enhanced Differential Diagnosis of Rectal Cancer
RECRUITING · NA
-
Mediterranean Diet and Weight Loss: Targeting the Bile Acid/Gut Microbiome Axis to Reduce Colorectal Cancer
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02602769 · 12 participants
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome
- NCT02605421 · 12 participants · Phase 2
Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma
- NCT02619448 · 12 participants · Early Phase 1
Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
- NCT03311503 · 12 participants · Phase 1
Phase I/II Trial of Lentiviral Gene Transfer for SCID-X1 With Low Dose Targeted Busulfan Conditioning
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI