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RECRUITING NA

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility

NCT05332639 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 80 participants
Start Date 2025-10-03
Est. Completion 2027-11
Phase NA

Sponsor

Massachusetts General Hospital

1,948 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05332639

The ClinicalTrials.gov registry entry for NCT05332639 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05332639 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05332639?

This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial