Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Diagnosetest: fecal calprotectin test
Fecal calprotectin detection by magnetic particle chemiluminescence assay

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cut-off value and predictive efficacy of the early decline in fecal calprotectin for mucosal healing
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cutoff value and predictive performance of fecal calprotectin reduction for predicting sustained clinical response
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tang-Du Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

18. Juni 2026

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

28. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • FCTSTUDY001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Colitis ulcerosa (UC)

Klinische Studien zur fecal calprotectin test

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Thailand

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren