Personalized Risk Estimation Tool for Crohn's Disease

Overseen By Emily W Lopes, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

80 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool treatment?

Research shows that identifying patients at risk for complications in Crohn's disease can help target early treatments to prevent issues like surgery and hospitalizations. This suggests that tools like PRE-CD, which estimate risk, could be effective in guiding early interventions to improve patient outcomes. ^{1 2 3 4 5}

How is the PRE-CD tool treatment different from other treatments for Crohn's disease?

The PRE-CD tool is unique because it uses personalized risk estimation, likely incorporating genetic and machine learning techniques, to predict disease progression and complications in Crohn's disease, allowing for more tailored treatment decisions compared to standard approaches. ^{5 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Emily W. Lopes, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals over 14 years old who have a first-degree relative with inflammatory bowel disease but do not show signs of the disease themselves. They must be able to understand and fill out questionnaires, give informed consent, and follow all study procedures.

Inclusion Criteria

I have a close family member with inflammatory bowel disease.

Ability to understand and complete study questionnaires

I am older than 14 years.

Exclusion Criteria

Inability or unwillingness to comply with all patient visits and study-related procedures

I have been diagnosed with an inflammatory bowel disease.

Inability to understand or complete study questionnaires

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the PRE-Crohn's tool or receive standard Crohn's disease education

8 weeks

Initial visit for tool introduction and education

Follow-up

Participants are monitored for changes in biomarkers and behaviors

6 months

Follow-up assessments at 8 weeks and 6 months

Study Completion

Final assessment of enrollment and retention rates

1.5 years

Treatment Details

Interventions

• Personalized Risk Estimation for Crohn's Disease (PRE-CD) tool
• Standard Crohn's Disease Education

Trial Overview The study tests a web-based tool called PRE-CD that estimates personal risk for Crohn's Disease against standard education on the condition. It aims to see if this tool can change behaviors and improve biomarkers related to Crohn's Disease risk in high-risk individuals.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool

Group II: Comparator arm Active Control 1 Intervention

Standard Crohn's Disease Education

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

American College of Gastroenterology

Collaborator

Trials

40

Recruited

6,900+

References

1. England pubmed.ncbi.nlm.nih.gov

Development of Clinical Prediction Models for Surgery and Complications in Crohn's Disease. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Risk Stratification of Patients with Crohn's Disease: A Retrospective Analysis of Clinical Decision Making and Its Impact on Long-Term Outcome. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Real-World Surgical and Endoscopic Recurrence Based on Risk Profiles and Prophylaxis Utilization in Postoperative Crohn's Disease. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The Pediatric Crohn Disease Morbidity Index (PCD-MI): Development of a Tool to Assess Long-Term Disease Burden Using a Data-Driven Approach. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Machine learning identifies novel blood protein predictors of penetrating and stricturing complications in newly diagnosed paediatric Crohn's disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Modeling the role of genetic factors in characterizing extra-intestinal manifestations in Crohn's disease patients: does this improve outcome predictions? [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Multi-locus genetic risk score predicts risk for Crohn's disease in Slovenian population. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Large sample size, wide variant spectrum, and advanced machine-learning technique boost risk prediction for inflammatory bowel disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

How does genotype influence disease phenotype in inflammatory bowel disease? [2022]