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A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers

17 augusti 2026 uppdaterad av: Xijing Hospital

A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers

This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

5000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
      • Jinan, Kina
        • Rekrytering
        • The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
        • Kontakt:
      • Mianyang, Kina
        • Rekrytering
        • Yanting County Tumor Hospital
        • Kontakt:
      • Wuwei, Kina
        • Rekrytering
        • Wuwei Cancer Hospital of Gansu Province
        • Kontakt:
      • Wuxi, Kina
        • Rekrytering
        • Wuxi People's Hospital
        • Kontakt:
      • Zhaoqing, Kina
        • Rekrytering
        • Zhaoqing First People's Hospital, Guangdong Province
        • Kontakt:
    • Guangdong
      • Zhaoqing, Guangdong, Kina
        • Rekrytering
        • Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
        • Kontakt:
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710032
        • Rekrytering
        • The First Affiliated Hospital of Air Force Military Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.

Beskrivning

Inclusion Criteria:

  • 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.

Exclusion Criteria:

  • 1. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard
Tidsram: Day 1 At endoscopy and pathological confirmation after enrollment
Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
Tidsram: Day 1 At endoscopy and pathological confirmation after enrollment
Day 1 At endoscopy and pathological confirmation after enrollment

Sekundära resultatmått

Resultatmått
Tidsram
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer
Tidsram: 5 years after enrollment
5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer
Tidsram: 5 years after enrollment
5 years after enrollment
Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.
Tidsram: 5 years after enrollment
5 years after enrollment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Xijing Hospital

Utredare

  • Huvudutredare: Yongzhan Nie, Xijing Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

10 augusti 2026

Primärt slutförande (Beräknad)

31 december 2035

Avslutad studie (Beräknad)

31 december 2035

Studieregistreringsdatum

Först inskickad

13 juli 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

18 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • KY20262029-C-1

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Applications shall be submitted to the principal investigator upon study completion. Applicants are required to provide a data analysis plan, and data sharing will be approved after assessment.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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