RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-07-14
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05332639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to give informed consent
  2. * Ability and willingness to comply with all patient visits and study-related procedures
  3. * Ability to understand and complete study questionnaires
  4. * Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)
  5. * Individuals greater than 14 years of age
  1. * Inability to provide informed consent
  2. * Inability to comply with all patient visits and study-related procedures
  3. * Inability to understand or complete study questionnaires
  4. * Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
  5. * Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity

Contacts and Locations

Study Contact

Emily W Lopes, MD
CONTACT
617-726-5560
mghprecrohns@mgb.org

Principal Investigator

Emily Lopes, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Emily Lopes, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-14
Study Completion Date2026-11

Study Record Updates

Study Start Date2025-07-14
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Crohn's disease

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Crohn Colitis
  • Crohn's Ileocolitis
  • Crohn's Gastritis
  • Crohn's Jejunitis
  • Crohn's Duodenitis
  • Crohn's Esophagitis