NCT04535882

Brief Summary

We attempt to examine the association between serum leucine-rich alpha-2 glycoprotein (LRG) levels and endoscopic activity in patients with possible ulcerative colitis (UC) or Crohn's disease (CD) to determine whether LRG was a predicting marker for UC or CD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.3 years

First QC Date

August 28, 2020

Last Update Submit

May 14, 2025

Conditions

LRG Levels

Outcome Measures

Primary Outcomes (1)

  • Serum LRG measurement

    Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients.

    one year

Interventions

serum leucine-rich alpha-2 glycoprotein (LRG) levelsDIAGNOSTIC_TEST

Patients who were diagnosed with possible UC or Crohn disease according to endoscopic, radiological, histological, and clinical criteria were enrolled. Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy were performed within 7 days.

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In total, a consecutive cohort of 300 patients with possible UC or CD will be enrolled in this study at our hospital.

You may qualify if:

  • Patients whom possible UC or Crohn disease was suspected

You may not qualify if:

  • other autoimmune diseases
  • acute or chronic renal failure
  • chronic heart diseases
  • liver cirrhosis
  • cancer
  • acute or chronic infections
  • ischemic colitis
  • infectious colitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General Hospital

Komagane, Nagano, 399-4117, Japan

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 2, 2020

Study Start

October 1, 2020

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations

JP(1)