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The Biologic Onset of Crohn's Disease: A Screening Study in First Degree Relatives

NCT03291743 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2022-12-13

No results posted yet for this study

Summary

Pursuing very early diagnosis is standard of care for several diseases including colon cancer, diabetes and liver disease where an early and aggressive diagnostic and therapeutic approach has been shown to change their natural history. Crohn's disease \[CD\] still lags since commonly at presentation CD has already run a long course, often responding poorly to therapy or requiring surgery. This innovative project proposes a minimally invasive strategy - capsule endoscopy-based screening of first degree relatives \[FDR's\] of CD patients - to develop tools to diagnose CD at or near its biologic onset.

Conditions

  • Crohn Disease
  • Genetic Predisposition
  • IBD

Interventions

DEVICE

Capsule endoscopy

PillCam(TM) CROHN'S CAPSULE

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • Dario R Sorrentino, MD, FRACP · Carilion Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2022-09-30
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03291743 on ClinicalTrials.gov