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MILESTONE-CD -A Prospective Multiomic Inception Real -Life Study To Evaluate Predictors of Disease Outcomes & respoNse to Biologic Treatment in Crohn's Disease (MILESTONE-CD)

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ClinicalTrials.gov Identifier: NCT04612621
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Study Description
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Brief Summary:

Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least 30% of the patients. The course of disease is extremely diverse, ranging from a very mild disease to a devastating and incapacitating course. The burden of inflammatory bowel disease is growing each disease, reaching 400 billion USD for lifetime in US. In Israel, there are currently over 50000 IBD patients, with one of the highest incidences in the word, multiple treatment modalities and medications are available for Crohn's disease, however the efficacy is limited and the costs- very high. Furthermore, long-term exposure to some of the therapeutic agents poses an increased risk of infections and cancer.

Some of the major challenges in IBD include prediction of disease course (some patients will require early and aggressive treatment while others may just need observation and follow-up), and treatment personalization (right drug for the right patient at the right time). Unfortunately, individualized predictors of disease course and response to treatment are currently very limited. Some clues can be derived from imaging and endoscopy data, transcriptomics, genomic and microbiome, however those are still very premature and impractical. Moreover, large-scale studies with sophisticated predictive models that incorporate multilayered and multilayered clinical and omic data are severely lacking.


Condition or disease Intervention/treatment Phase
Crohn Disease of Intestine Diagnostic Test: combination of diagnostic tests Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 149 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled patients will undergo similar interventions
Masking: None (Open Label)
Primary Purpose: Other
Official Title: MILESTONE-CD -A Prospective Multiomic Inception Real -Life Study To Evaluate Predictors of Disease Outcomes & respoNse to Biologic Treatment in Crohn's Disease
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Intervention Details:
  • Diagnostic Test: combination of diagnostic tests
    capsule endoscopy, MRE , intestinal ultrasound, fecal microbiota, blood and serum biomarkers as described

Outcome Measures
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Primary Outcome Measures :
  1. failure of first biologic [ Time Frame: 2 years ]
    cessation or switch of first biologic as per decision of the treating physician (documentation of change of therapy from the first biologic for any reason)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Crohn's disease
  • Start of first-line biological therapy

Exclusion Criteria:

  • Previous biologic therapy
  • Previous surgery
Contacts and Locations
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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): NCT04612621


Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Miri Lipkin, BSC    03507079    Miri.LipkinBony@sheba.health.gov.il   
Sponsors and Collaborators
Sheba Medical Center
More Information
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04612621    
Other Study ID Numbers: SHEBA-20-7346-UK-CTIL
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases