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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） (PRECAL)

20 luglio 2026 aggiornato da: Tang-Du Hospital

Predictive Efficacy of Fecal Calprotectin Assay by Magnetic Particle Chemiluminescence for Mucosal Healing in Moderate-to-Severe Ulcerative Colitis Patients Undergoing Initial Biologic Therapy: A Prospective, Multicenter, Observational Clinical Study

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.

Panoramica dello studio

Stato

Iscrizione su invito

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Ulcerative colitis (UC) is a chronic non-specific inflammatory bowel disease that mainly affects the rectum and colon. It is characterized by frequent relapse and protracted course. Its incidence has been rising rapidly, imposing a substantial economic burden on both patients and society. Biologic agents serve as key therapeutic options for UC and are widely used in the management of patients with moderate-to-severe disease. Mucosal healing (MH) is a core therapeutic goal for UC. Endoscopy is the primary modality to assess endoscopic MH, yet it is an invasive examination.

Fecal calprotectin (FC) is a specific biomarker for intestinal inflammation, which can accurately reflect the inflammatory status of the gut and acts as an ideal non-invasive biomarker for patients with UC. A large number of existing studies have demonstrated that FC is strongly correlated with clinical disease activity, endoscopic findings and histological parameters, highlighting its great value in disease assessment.

Magnetic particle chemiluminescence assay features high sensitivity, rapid detection, wide linear range, excellent precision and accuracy, as well as high degree of automation. It enables full-course monitoring of FC levels across mild, moderate and severe inflammatory stages as well as disease remission, providing evidence for evaluating therapeutic efficacy and optimizing treatment regimens. Hence, it is an optimal method for detecting FC concentrations.

This is a national prospective, multicenter, observational study. Eligible participants are patients aged 18 years or older with moderate-to-severe active UC, disease extent classified as Montreal E2 or E3, newly initiated biologic therapy, and a confirmed UC diagnosis of more than 3 months. The total follow-up duration is 30 to 32 weeks. During follow-up, stool samples are collected for FC measurement, along with clinical data and endoscopic results of the enrolled patients.

The study endpoints are defined as endoscopic mucosal healing, clinically confirmed inadequate response to the current biologic therapy (where continued treatment is unlikely to achieve mucosal healing, necessitating treatment switching or combined medication), or completion of the 30-32-week follow-up.

The primary objective is to determine the cutoff value and predictive performance of the early (Weeks 2-4) reduction in FC measured by magnetic particle chemiluminescence assay for predicting mucosal healing in moderate-to-severe UC patients receiving initial biologic therapy.

The secondary objectives are as follows:

  1. To identify the cutoff value and predictive performance of the early (Weeks 2-4) FC reduction detected via magnetic particle chemiluminescence assay for predicting sustained clinical response in moderate-to-severe UC patients on initial biologic therapy;
  2. To explore the cutoff value and predictive performance of the early (Weeks 2-4) FC reduction for predicting sustained endoscopic remission in the above patient population;
  3. To analyze the dynamic correlation between FC levels measured by magnetic particle chemiluminescence assay and clinical disease activity;
  4. To assess the correlation between FC levels and endoscopic disease activity;
  5. To establish a predictive model for mucosal healing at Weeks 30-32 in UC patients by combining symptom scores, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), FC levels and their reduction ranges.

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
      • Dalian, Cina, 116023
        • The Second Hospital of Dalian Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100044
        • Peking University People's Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Cina, 401121
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, Cina, 518101
        • Shenzhen Hospital, Southern Medical University
    • Hubei
      • Wuhan, Hubei, Cina, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210009
        • Zhongda Hospital, Southeast University
    • Liaoning
      • Shengyang, Liaoning, Cina, 110004
        • Shengjing Hospital of China Medical University,
    • Shandong
      • Qingdao, Shandong, Cina, 266035
        • Qilu Hospital (Qingdao), Shandong University
    • Shanxi
      • Xi’an, Shanxi, Cina, 710038
        • Tangdu Hospital, Air Force Medical University
      • Xi’an, Shanxi, Cina, 710077
        • The First Affiliated Hospital of Xi'an Medical University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Test diagnostico: fecal calprotectin test
Fecal calprotectin detection by magnetic particle chemiluminescence assay

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing
Lasso di tempo: From enrollment to at the end of 30-32 weeks
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained clinical response
Lasso di tempo: From enrollment to at the end of 30-32 weeks follow-up
clinical symptom remission is defined as a score of 0 for both Stool Frequency (SF) and Rectal Bleeding(RB) in the Mayo score; or a score of 0 for RB, plus an SF score of ≤1 with a reduction of at least 1 point from baseline
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
Lasso di tempo: From enrollment to at the end of 30-32 weeks follow-up
Endoscopic remission is defined as an endoscopic subscore of 0 or 1 in the Mayo score (excluding the finding of mucosal friability)
From enrollment to at the end of 30-32 weeks follow-up
Dynamic correlation between fecal calprotectin levels and clinical disease activity
Lasso di tempo: From enrollment to at the end of 30-32 weeks follow-up
Fecal calprotectin and Mayo score data will be collected at each follow-up time point to analyze their dynamic correlation
From enrollment to at the end of 30-32 weeks follow-up
Correlation between fecal calprotectin levels and endoscopic disease activity.
Lasso di tempo: From enrollment to at the end of 30-32 weeks follow-up
Fecal calprotectin and Mayo endoscopic subscore data will be collected at each follow-up time point to assess their correlation.
From enrollment to at the end of 30-32 weeks follow-up

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: From enrollment to at the end of 30-32 weeks follow-up
Multivariate regression analysis will be performed using patients' demographic data, disease characteristics, medication information, Mayo scores, ESR, CRP and fecal calprotectin levels, so as to develop a predictive model for mucosal healing at Weeks 30-32 among moderate-to-severe ulcerative colitis patients treated with biologic agents.
From enrollment to at the end of 30-32 weeks follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tang-Du Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 giugno 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 ottobre 2027

Date di iscrizione allo studio

Primo inviato

28 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

20 luglio 2026

Primo Inserito (Effettivo)

23 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FCTSTUDY001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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