Association Between LRG and Histologic Remission in Ulcerative Colitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis in Histologic Remission. Basic parameters: 20 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
What is the Level of Serum Leucine-rich α 2-glycoprotein (LRG) Which Predicts Histologic Remission in Patients With Ulcerative Colitis?
Overview
We attempt to clarify the serum leucine-rich α 2-glycoprotein (LRG) level which can predict histologic remission in ulcerative colitis patients in this study. Colonoscopy with histology will be performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay.
Detailed description
Aim: Serum leucine-rich α 2-glycoprotein (LRG) may be a noninvasive biomarker for monitoring disease activity in patients with ulcerative colitis (UC). We attempt to clarify the LRG level which predicts histologic remission in UC patients in this study.
Methods: Patients with UC were consecutively enrolled with the measurement of serum LRG. Colonoscopy with histology is performed when histologic remission is predicted, irrespective of symptoms or serum LRG values. Serum LRG levels are analyzed by an enzyme-linked immunosorbent assay. For the evaluation of UC activity, clinical remission was defined as score 1 or 0 using the partial Mayo score and endoscopic remission was defined as score 0 using the Mayo endoscopic subscore. And histologic remission is defined as \< grade 2 using Geboes score. We analyze the area under receiver operating characteristic (ROC) curves to evaluate the diagnostic ability of LRG for predicting histologic remission of UC.
Primary outcome measures
- Histologic remission of UC [Time frame: 1 week]
Secondary outcome measures (1)
- Endoscopic remission [Time frame: 1 week]
Eligibility criteria
Inclusion criteria
- active UC patients
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Showa Inan General Hospital — Komagane
Identifiers
NCT: NCT06372613 · LRG&UC