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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291743
Recruitment Status : Recruiting
First Posted : September 25, 2017
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dario Sorrentino, Carilion Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Genetic Predisposition IBD Device: Capsule endoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Biologic Onset of Crohn's Disease: A Screening Study in First Degree Relatives
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: First Degree Relative
A total of 112 high risk first-degree relatives will be enrolled in total. Patients with Crohn's Disease will be given information about the study when in clinic for routine care to share with their first degree relatives (FDR). Screening will be done using capsule endoscopy.
Device: Capsule endoscopy
PillCam(TM) CROHN'S CAPSULE
Other Name: PillCam(TM)

Active Comparator: Healthy Controls
This study will also enroll 35 healthy controls who will be age and sex matched to the first degree relative (FDR) population. Enrollment will begin after 20-25 FDR's have passed screening and will continue at this interval until all controls have been enrolled. Controls will be initially screened by colonoscopy. If enrolled they will undergo capsule endoscopy as well
Device: Capsule endoscopy
PillCam(TM) CROHN'S CAPSULE
Other Name: PillCam(TM)




Primary Outcome Measures :
  1. Prevalence of Crohn's Disease in First Degree Relatives by capsule endoscopy screening [ Time Frame: coincident at screening ]
    This study will screen asymptomatic, first-degree relatives of patients with established Crohn's Disease to detect the disease at or near its biologic onset.


Secondary Outcome Measures :
  1. Correlation of capsule endoscopy with ileocolonoscopy; characterization of disease state [ Time Frame: coincident at screening ]
    Evaluate the accuracy of capsule endoscopy (CE) in screening for pre-clinical Crohn's Disease by verifying CE findings with ileocolonoscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female who are 18-65 years of age
  • FDR: Has a first degree relative (mother, father, offspring, or full sibling) who has been diagnosed with Crohn's Disease Healthy Controls: Normal colonoscopy and histology (if applicable) results, and no family history of inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis)
  • Willingness to comply with protocol requirements, timelines, and procedures
  • Must be able and willing to provide written consent; medical, surgical, and medication history; current and concomitant medication use; and any other documents deemed relevant by the investigator.
  • A negative pregnancy test for all female subjects of childbearing potential at the time of consent. Subject must also agree to follow medically approved birth control measures while enrolled

Exclusion Criteria:

  • Suspected or confirmed diagnosis of inflammatory bowel disease or any other gastrointestinal disease or condition
  • Known medical history of clinically significant cardiovascular, hematologic, orthopedic, rheumatologic, muscular, neurologic (e.g. dementia, seizure disorder, traumatic brain injury), endocrine, ophthalmologic, infectious (e.g. human immunodeficiency virus, tuberculosis, hepatitis), immunologic, renal, pulmonary (e.g. COPD), dermatologic, reproductive, or psychiatric disorders, conditions, or diseases that would present unacceptable risk to study subjects, compromise the acquisition or interpretation of study data, or otherwise interfere with the study subject's participation
  • A systolic blood pressure reading ≥ 180 mmHg and/or a diastolic blood pressure reading of ≥ 110 mmHg at screening
  • An oral temperature reading of 100.5º F or greater
  • Meets any of the following criteria:

    • Use of systemic non-steroidal anti-inflammatory medication (including low-dose aspirin) within 14 days prior to consent
    • History of oral corticosteroid use within 30 days prior to consent
    • Use of IV corticosteroids within 14 days prior to consent
    • Treatment with IV anti-infectives within 30 days prior to consent
    • Treatment with oral anti-infectives within 14 days prior to consent
  • Previous or current history of malignancy (including fully excised cutaneous basal cell carcinoma and squamous cell carcinoma)
  • History of stem cell or fecal transplant
  • History of clinically significant alcoholism or substance abuse in the last 12 months, as defined in the DSM-IV
  • Currently has an implanted electrical device (e.g., pacemaker)
  • Screening lab results were found to be exclusionary based on the following

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291743


Contacts
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Contact: Dario R Sorrentino, MD, FRACP 540-224-5170 drsorrentino@carilionclinic.org
Contact: Vu Q Nguyen, MD 540-206-9226 vqnguyen@carilionclinic.org

Locations
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United States, Virginia
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24013
Contact: Andrea L Bidanset, MS    540-224-6751    albidanset@carilionclinic.org   
Sponsors and Collaborators
Dario Sorrentino
Investigators
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Principal Investigator: Dario R Sorrentino, MD, FRACP Carilion Clinic

Publications:

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Responsible Party: Dario Sorrentino, MD, FRACP, Director, Inflammatory Bowel Diseases, Carilion Clinic
ClinicalTrials.gov Identifier: NCT03291743    
Other Study ID Numbers: RTDB-2201
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dario Sorrentino, Carilion Clinic:
Crohn's
Capsule endoscopy
IBD
Additional relevant MeSH terms:
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Crohn Disease
Disease Susceptibility
Genetic Predisposition to Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes