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NCT07563166

Clinicopathologic Features and Staging Risk Factors of Early-Onset Colorectal Cancer

Sponsor: Run-hua Li

View on ClinicalTrials.gov

Summary

This study aims to characterize the clinical and pathological features of early-onset colorectal cancer (EO-CRC; diagnosis at age ≤50) and to identify factors associated with more advanced tumor stage. The investigators will compare patients with early-stage disease (high-grade intraepithelial neoplasia, carcinoma in situ \[Tis\], and T1) to those with later-stage disease (T2 and above) to identify characteristics predictive of advanced staging. Adults aged ≤50 years with a pathological diagnosis of colorectal cancer or high-grade intraepithelial neoplasia at Shenzhen Hospital, Southern Medical University between January 2016 and September 2025 will be eligible for inclusion if clinical, endoscopic, and pathology records are available. This retrospective observational study will use existing medical records; no experimental treatments or additional procedures will be performed. De-identified information will be extracted from medical records, including demographics, symptoms, lifestyle factors, laboratory tests, endoscopic and imaging findings, pathology reports, treatments received, and follow-up outcomes. Data will be handled securely, stored using subject codes, and analyzed to compare groups and to develop statistical models that identify independent risk factors for advanced tumor stage. Participation involves no direct contact or additional testing for participants and poses minimal risk because only previously collected, de-identified data are used. Findings may inform improvements in early detection, risk stratification, and management strategies for younger patients with colorectal neoplasia.

Official title: Clinicopathologic Characteristics and Tumor Staging-Related Risk Factors of Early-Onset Colorectal Cancer: A Retrospective Cohort Study at Shenzhen Hospital, Southern Medical University

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2026-01-30

Completion Date

2026-03-31

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

OTHER

Observational (Retrospective Data Analysis)

No experimental or study-specific intervention. This study uses de-identified, retrospective clinical, endoscopic, imaging, laboratory, pathology, treatment, and follow-up data from routine care (2016-01-01 to 2025-09-30). Cohort membership is defined by pathological diagnosis (EO-CRC or HGIN) and analyses will stratify by stage. Data handling includes de-identification, subject coding, double data extraction, logic checks, and secure storage; no additional procedures or contacts with patients will occur.

Locations (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, China