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A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model

12. august 2026 oppdatert av: Xijing Hospital

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

10000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Underwent upper gastrointestinal endoscopy screening within the past year;
  • History of any type of malignant tumor;
  • 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;
  • 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);
  • Pregnant or breastfeeding women.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: kontrollgruppe
Eksperimentell: Intervensjonsgruppe
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.

Hva måler studien?

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
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
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Tidsramme: Baseline
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xijing Hospital

Samarbeidspartnere

Wuxi People's Hospital
Zhaoqing Gaoyao People's Hospital
Gansu Wuwei Tumor Hospital
The 960th Hospital of PLA
Yanting County Tumor Hospital
First People's Hospital of Zhaoqing

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juni 2026

Primær fullføring (Antatt)

31. desember 2035

Studiet fullført (Antatt)

31. desember 2035

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. august 2026

Sist bekreftet

1. januar 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KY20262032-C-1

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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