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NCT05332639 · ClinicalTrials.gov registry record · NA
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
A NA study of Crohn Disease and Inflammatory Bowel Diseases, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05332639: Recruiting NA study of Crohn Disease and Inflammatory Bowel Diseases, sponsored by Massachusetts General Hospital.
NCT05332639 is a NA study of Crohn Disease and Inflammatory Bowel Diseases that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 204-participant average among 71 other Crohn Disease trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05332639, a NA study of Crohn Disease and Inflammatory Bowel Diseases, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.
Primary Outcome
The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey.
Conditions Studied
Interventions
- BEHAVIORAL Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
- BEHAVIORAL Standard Crohn's Disease Education
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-10-03 |
| Est. Completion | 2027-11 |
| Phase | NA |
What NCT05332639 shows while recruiting
NCT05332639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 204-participant average among 71 other Crohn Disease trials with a reported enrollment target (61% lower).
The record links to 8 conditions, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions - of which Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool is the first listed.
NCT05332639 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05332639 about?
NCT05332639 is a clinical study titled "Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility". The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel ...
What is the current status of trial NCT05332639?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-10-03. Estimated completion is 2027-11.
What conditions does trial NCT05332639 study?
This clinical trial studies the following conditions: Crohn Disease, Inflammatory Bowel Diseases, Crohn's Ileocolitis, Crohn's Gastritis, Crohn's Jejunitis.
What interventions are being tested in trial NCT05332639?
The interventions under investigation include: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool (BEHAVIORAL), Standard Crohn's Disease Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT05332639?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05332639 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05332639's enrollment target sits among peer trials
80 38th of 71 higher than 34 of 71 other Crohn Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn Disease 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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