Showa Inan General Hospital
Komagane, Japan
Location status: Recruiting
Location contact
Akira Horiuchi
CONTACT
Recruiting
NCT Number: NCT06372613
Association Between LRG and Histologic Remission in Ulcerative Colitis
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.
Recruiting
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Request InfoKey information
Conditions
Age range
20 year–90 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- active UC patients
Exclusion criteria
- None
Treatment and study plan
Primary outcomes
-
Histologic remission of UC
Time frame: 1 week
Histologic remission is defined as < grade 2 using Geboes score.
Secondary outcomes
-
Endoscopic remission
Time frame: 1 week
Endoscopic remission is defined as score 0 using the Mayo endoscopic subscore.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Showa Inan General Hospital
Other
Registry information
Official study title
What is the Level of Serum Leucine-rich α 2-glycoprotein (LRG) Which Predicts Histologic Remission in Patients With Ulcerative Colitis?
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 18, 2024
- Registry last updated
- Apr 24, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.