Risk Factors Clinical Trial
Official title:
Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors: a Prospective, Multicenter Cross-sectional Study
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.
| Status | Not yet recruiting |
| Enrollment | 6250 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Individuals aged 18-80 who undergo both gastroscopy and colonoscopy simultaneously Exclusion Criteria: - (1)Previously diagnosed with esophageal, gastric, or colorectal cancer; (2) Suspected presence of gastrointestinal obstruction or perforation; (3) Previous history of esophageal, gastric, or colorectal surgery; (4) Those who are not suitable for endoscopic examination due to serious diseases or unstable hemodynamics; (5) Individuals who are unable to obtain relevant information due to communication barriers such as mental or neurological disorders; (6) Pregnancy or lactation period; (7) Not willing or unable to sign the informed consent form. |
| Country | Name | City | State |
|---|---|---|---|
| China | Xijing of Digestive Diseases | Xi'an | Shaanxi |
| Lead Sponsor | Collaborator |
|---|---|
| Air Force Military Medical University, China |
China,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall detection rate of gastrointestinal cancer | The proportion of at least one type of gastrointestinal malignant tumor detected | 2 years |
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