Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors

NCT ID: NCT06118437

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-15

Study Completion Date

2025-07-31

Brief Summary

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Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important.

Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models.

Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.

Detailed Description

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Conditions

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Malignant Tumor of Digestive Tract Risk Factors

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Individuals aged 18-80;
* Undergoing both gastroscopy and colonoscopy simultaneously.

Exclusion Criteria

* History of esophageal, gastric, or colorectal cancer;
* Suspicions of gastrointestinal obstruction or perforation;
* History of gastrointestinal tract surgery;
* Not suitable for endoscopic examination due to serious diseases or unstable hemodynamics;
* Unavailable relevant information;
* Pregnancy or lactation period;
* Unavailable informed consent form.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xijing of Digestive Diseases

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang lin Pan, MD

Role: CONTACT

862984771536

Facility Contacts

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Yang lin Pan, MD

Role: primary

862984771536

References

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Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

Reference Type BACKGROUND
PMID: 33538338 (View on PubMed)

Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.

Reference Type BACKGROUND
PMID: 34176681 (View on PubMed)

Other Identifiers

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XJLL-KY-20232231

Identifier Type: -

Identifier Source: org_study_id

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