LRG LevelsNCT04535882
Effectiveness of Serum Leucine-rich Alpha-2 Glycoprotein Levels on IBD
An observational study of LRG Levels, run by Showa Inan General Hospital at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- LRG Levels
- What is being tested?
- serum leucine-rich alpha-2 glycoprotein (LRG) levels
- How many people
- 673 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2020to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In total, a consecutive cohort of 300 patients with possible UC or CD will be enrolled in this study at our hospital.
Who may be able to join
- Patients whom possible UC or Crohn disease was suspected
Who cannot join
- other autoimmune diseases
- acute or chronic renal failure
- chronic heart diseases
- liver cirrhosis
- cancer
- acute or chronic systemic infections
- ischemic colitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis
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.
Read the detailed description
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 with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group.
CD patients whose CDAI >150 were divided into the active CD group.
- Conditions
- LRG Levels
- Being tested
- serum leucine-rich alpha-2 glycoprotein (LRG) levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LRG LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Showa Inan General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akira Horiuchi, Showa Inan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535882
- Sponsor's protocol ID
- LRG
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2020
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum Leucine-rich Alpha-2 Glycoprotein Levels and Endoscopic Activity of Possible Ulcerative Colitis or Crohn's Disease Colitis
- ClinicalTrials.gov ID
- NCT04535882
- Acronym / sponsor ID
- LRG
- Conditions
- LRG Levels
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 673 participants (actual)
- Lead sponsor
- Showa Inan General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 with histology were performed within 7 days.The disease activity of UC and CD patients was evaluated by the Mayo score and Crohn disease activity index (CDAI), respectively. The Mayo endoscopy score was evaluated. UC patients whose Mayo endoscopy score was 2 or 3 were divided into the active UC group.
CD patients whose CDAI >150 were divided into the active CD group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In total, a consecutive cohort of 300 patients with possible UC or CD will be enrolled in this study at our hospital.
Key inclusion criteria (1 listed)
- Patients whom possible UC or Crohn disease was suspected
Key exclusion criteria (7 listed)
- other autoimmune diseases
- acute or chronic renal failure
- chronic heart diseases
- liver cirrhosis
- cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum leucine-rich alpha-2 glycoprotein (LRG) levelsPatients 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. | Diagnostic test | – |
Primary outcome
Serum LRG measurement
Time frame: one year
Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Related trials for LRG Levels
RecruitingObservational study
Association Between LRG and Histologic Remission in Ulcerative Colitis
Ulcerative Colitis in Histologic Remission
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of LRG Levels, run by Showa Inan General Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum LRG measurement (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.