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NCT03646708 · ClinicalTrials.gov registry record
Response Assessment in SB CD
A clinical trial of Small Bowel Crohn's Disease, sponsored by Washington University School of Medicine.
- Active
- Registry status
- 112
- Enrollment target
- 1
- Study location
NCT03646708 is a study of Small Bowel Crohn's Disease that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 112 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03646708, a study of Small Bowel Crohn's Disease, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- 112 participants
- Enrollment target
- 1
- Study location
Study Summary
The small bowel (SB) is involved in \~70% of patients with Crohn's disease (CD). There is an unmet need for accurate and clinically meaningful methods to measure small bowel Crohn's Disease (SBCD) activity. This is particularly relevant as the field moves towards "treat-to-target" management strategies. The overall objective of this proposal is to establish that radiologic transmural response (TR) and a novel proteomic biomarker are accurate and clinically meaningful predictors of SBCD inflammatory activity and response to biologic therapy. To address this objective, we will establish a prospectively followed cohort of SBCD patients starting a new biologic therapy. These patients will be comprehensively phenotyped using state of the art MRE imaging, proteomic profiling and clinical disease activity indices. We will use this innovative approach of triangular phenotyping to address our central hypothesis that "Corticosteroid-free remission at 52 weeks after biologic therapy initiation is predicted by short term radiologic TR or early changes in serum proteomic biomarker profiles". Serum proteomic biomarker profiles will be evaluated using SOMAscanTM (SomaLogic, Inc., Boulder, Colorado, USA), a novel platform allowing high-throughput analysis of proteins through Slow Off-rate Modified DNA Aptamer (SOMAmer)-based capture array. Our preliminary data using SOMAscan identified a panel of 12 serum proteins whose differential expression pattern from Week 0 to week 6 after starting a biologic can predict week 14 clinical remission in SBCD patients. The significance of this proposal is that the development of an early predictive model using radiological and serum endpoints will facilitate a personalized algorithmic approach to identify patients with SBCD who will benefit from treatment escalation or change to a different biologic. Furthermore, it will be used to generate a tangible career tool of a prospectively enrolled patient cohort to further study radiologic and biomarker
Conditions Studied
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2018-05-09 |
| Est. Completion | 2027-05-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03646708
The ClinicalTrials.gov registry entry for NCT03646708 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Small Bowel Crohn's Disease appearing as the primary indexed condition, and to 0 interventions.
NCT03646708 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT03646708 about?
NCT03646708 is a clinical study titled "Response Assessment in SB CD". The small bowel (SB) is involved in \~70% of patients with Crohn's disease (CD). There is an unmet need for accurate and clinically meaningful methods to measure small bowel Crohn's Disease (SBCD) activity. This is particularly relevant as the field moves towards "treat-to-target" management strateg...
What is the current status of trial NCT03646708?
This trial is currently active not recruiting. The enrollment target is 112 participants. The study started on 2018-05-09. Estimated completion is 2027-05-30.
What conditions does trial NCT03646708 study?
This clinical trial studies the following conditions: Small Bowel Crohn's Disease.
Who is sponsoring clinical trial NCT03646708?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03646708 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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