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）

Enrolling by invitation

Conditions studied: Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07721441

Run by

Tang-Du Hospital

People needed

200

Starts

2026-06-18

Expected to finish

2027-10-30

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Peking University People's Hospital — Beijing, Beijing Municipality, China
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China
• Shenzhen Hospital, Southern Medical University — Shenzhen, Guangdong, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China
• Zhongda Hospital, Southeast University — Nanjing, Jiangsu, China
• Shengjing Hospital of China Medical University, — Shengyang, Liaoning, China
• Qilu Hospital (Qingdao), Shandong University — Qingdao, Shandong, China
• Tangdu Hospital, Air Force Medical University — Xi’an, Shanxi, China
• The First Affiliated Hospital of Xi'an Medical University — Xi’an, Shanxi, China
• The Second Hospital of Dalian Medical University — Dalian, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.