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A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial

13. juli 2026 opdateret af: Xijing Hospital
This study is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo standard gastrointestinal endoscopy, while those with negative results will enter routine observation; the other group will undergo only routine observation and follow-up. All enrolled participants will undergo a 5-year prospective follow-up, during which information on gastrointestinal cancer incidence and mortality will be collected through regular contact and review of medical records. The primary endpoint of the study is the difference in 5-year all-gastrointestinal cancer mortality between the two groups.This project aims to use a randomized controlled trial design to evaluate whether an active screening strategy based on a combined model can effectively reduce the population-level mortality from gastrointestinal cancers compared to routine surveillance. The objective is to provide high-level evidence for establishing a new screening strategy that reduces the disease burden and delivers public health benefits. It lays the foundation for validating novel biomarkers and exploring the biological and behavioral factors that influence screening outcomes, and offers clear decision-making support for optimizing China's comprehensive prevention and control system for gastrointestinal cancers.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Jinan, Kina
        • Rekruttering
        • The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
        • Kontakt:
      • Mianyang, Kina
        • Rekruttering
        • Yanting County Tumor Hospital
        • Kontakt:
      • Wuwei, Kina
        • Rekruttering
        • Wuwei Cancer Hospital of Gansu Province
        • Kontakt:
      • Wuxi, Kina
        • Rekruttering
        • Wuxi People's Hospital
        • Kontakt:
      • Zhaoqing, Kina
        • Rekruttering
        • Zhaoqing First People's Hospital, Guangdong Province
        • Kontakt:
    • Guangdong
      • Zhaoqing, Guangdong, Kina
        • Rekruttering
        • Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • 1) Participants must be between 45 and 74 years of age at the time of enrollment; 2) Participants must agree to be randomly assigned to different screening and follow-up strategies; 3) Participants must agree to undergo a five-year follow-up in accordance with the protocol; 4) Participants must be willing to participate and sign an informed consent form.

Exclusion Criteria:

  • 1) Underwent upper gastrointestinal endoscopy screening within the past year; 2) History of any type of malignant tumor; 3) Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders; 4) Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy); 5) Pregnant or breastfeeding women.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: kontrolgruppe
Eksperimentel: Interventionsgruppe
Diagnostisk test: Multi-target blood methylation + fecal FIT + fecal calprotectin
The intervention group underwent testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calprotectin"; those with positive results subsequently underwent standard gastrointestinal endoscopy, while those with negative results were placed under routine observation.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups.
Tidsramme: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.
Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.

Sekundære resultatmål

Resultatmål
Tidsramme
The incidence of gastrointestinal cancer in the two groups
Tidsramme: Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Tidsramme: Diagnostic performance metrics calculated based on baseline screening results and the gold standard of pathology
Diagnostic performance metrics calculated based on baseline screening results and the gold standard of pathology
All-cause mortality in the two groups
Tidsramme: All-cause mortality among all participants within 5 years of enrollment
All-cause mortality among all participants within 5 years of enrollment
Detection rate of precancerous lesions and early-stage gastrointestinal tumors
Tidsramme: At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
Incidence of endoscopy-related complications
Tidsramme: Incidence of various endoscopy-related complications observed within 5 years
Incidence of various endoscopy-related complications observed within 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xijing Hospital

Samarbejdspartnere

Wuxi People's Hospital
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing First People's Hospital, Guangdong Province
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Wuwei Cancer Hospital of Gansu Province
Yanting County Tumor Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juni 2026

Primær færdiggørelse (Anslået)

31. december 2035

Studieafslutning (Anslået)

31. december 2035

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juli 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY20262032-C-1

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gastrointestinale tumorer

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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