Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy（PRECAL）

NCT07721441 | Enrolling By Invitation

• 1 other identifier: FCTSTUDY001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 10

Brief Summary

This is a national prospective, multicenter, observational study. A total of 200 eligible patients will be enrolled from 10 hospitals across the country. Inclusion criteria are as follows: aged ≥ 18 years; diagnosed with moderate-to-severe active ulcerative colitis (UC); disease extent classified as E2 or E3; receiving biologic therapy for the first time; and having a confirmed UC diagnosis for more than 3 months. The follow-up period lasts 30-32 weeks. Six scheduled follow-up visits will be conducted at baseline, weeks 2-4, 6-8, 14-16, 22-24, and 30-32 after enrollment. The study endpoints are defined as: endoscopic mucosal healing (Mayo endoscopic score = 0 for UC), clinical judgment of inadequate response to current biologic therapy (i.e., continued treatment is unlikely to achieve mucosal healing and thus treatment switching or combined medication is required), or completion of the 30-32-week follow-up. The primary objective is to determine the cutoff value and predictive efficacy of the early (Weeks 2-4) reduction in fecal calprotectin (FC) measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients initiating biologic therapy.

Conditions

Ulcerative Colitis (UC)

Keywords

Fecal calprotectin; mucosal healing; ulcerative colitis; Biological agent

Outcome Measures

Primary Outcomes (1)

• Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing

  Mucosal healing was defined as an endoscopic subscore of 0 according to the modified Mayo score system for assessing ulcerative colitis disease activity

  From enrollment to at the end of 30-32 weeks

Secondary Outcomes (4)

• Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained clinical response

  From enrollment to at the end of 30-32 weeks follow-up

• Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained endoscopic remission

  From enrollment to at the end of 30-32 weeks follow-up

• Dynamic correlation between fecal calprotectin levels and clinical disease activity

  From enrollment to at the end of 30-32 weeks follow-up

• Correlation between fecal calprotectin levels and endoscopic disease activity.

  From enrollment to at the end of 30-32 weeks follow-up

Other Outcomes (1)

• Predictive model for mucosal healing at Weeks 30-32 in UC patients by combining symptom scores, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin levels and their decreasing ranges

  From enrollment to at the end of 30-32 weeks follow-up

Study Arms (1)

moderate-to-severe UC patients

Patients with ulcerative colitis who are aged ≥ 18 years, have moderate-to-severe disease activity, present with disease extent E2 or E3, receive biologic therapy for the first time, and have a confirmed diagnosis of ulcerative colitis for more than 3 months

Diagnostic Test: fecal calprotectin test

Interventions

fecal calprotectin test DIAGNOSTIC_TEST

Fecal calprotectin detection by magnetic particle chemiluminescence assay

moderate-to-severe UC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ulcerative colitis who are aged ≥ 18 years, have moderate-to-severe disease activity, present with disease extent E2 or E3, receive biologic therapy for the first time, and have a confirmed diagnosis of ulcerative colitis for more than 3 months

You may qualify if:

• Aged ≥ 18 years;
• Patients with ulcerative colitis receiving initial biologic therapy;
• Confirmed diagnosis of ulcerative colitis for more than 3 months;
• Moderate-to-severe disease activity;
• Disease extent classified as E2 or E3;
• Voluntarily signed the informed consent form and agreed to participate in this study.

You may not qualify if:

• Aged under 18 years;
• Patients who have previously received biologic therapy;
• Patients with ulcerative colitis of disease extent E1;
• Pregnant or lactating women;
• Patients with contraindications to biologic agents;
• Patients deemed unsuitable for this clinical study by clinical judgment.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (10)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401121, China

Location

Shenzhen Hospital, Southern Medical University

Shenzhen, Guangdong, 518101, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

Location

Shengjing Hospital of China Medical University,

Shengyang, Liaoning, 110004, China

Location

Qilu Hospital (Qingdao), Shandong University

Qingdao, Shandong, 266035, China

Location

Tangdu Hospital, Air Force Medical University

Xi’an, Shanxi, 710038, China

Location

The First Affiliated Hospital of Xi'an Medical University

Xi’an, Shanxi, 710077, China

Location

The Second Hospital of Dalian Medical University

Dalian, 116023, China

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 32 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 23, 2026
• Study Start: June 18, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)