Clinicopathologic Characteristics and Tumor Staging-Related Risk Factors of Early-Onset Colorectal Cancer: A Retrospective Cohort Study at Shenzhen Hospital, Southern Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 50 years
- •Pathologically confirmed colorectal neoplasia diagnosed at Shenzhen Hospital, Southern Medical University between 2016-01-01 and 2025-09-30, defined as colorectal cancer (any T stage) or high-grade intraepithelial neoplasia (HGIN).
- •Available source documentation: complete or retrievable clinical record, endoscopy report, and pathology report sufficient to determine diagnosis and stage.
- •De-identifiable data available for extraction (records can be coded and exported without direct identifiers).
- •No requirement for additional patient contact (retrospective use of existing records with IRB-approved consent waiver or documented consent per ethics approval).
排除标准
- •Secondary/metastatic colorectal tumor (colorectal involvement proven to be metastasis from another primary site).
- •Prior history of other active malignancy within the last 5 years that could confound staging or outcomes, unless disease is in long-term remission and clearly documented.
- •Insufficient documentation to determine pathological diagnosis or T stage (key pathology report missing or illegible).
- •Critical data missing for primary outcome (e.g., pathology date or staging information) that cannot be resolved after source review.
- •Duplicate records or irreconcilable data (same patient with conflicting identifiers/records that cannot be reconciled).
- •Patients who received initial diagnostic or therapeutic care outside the study site with no accessible pathology or endoscopy reports at Shenzhen Hospital.
研究组 & 干预措施
Single Retrospective Cohort
Adults ≤ 50 years diagnosed by pathology with colorectal cancer (any T stage) or high-grade intraepithelial neoplasia (HGIN) at Shenzhen Hospital, Southern Medical University between 2016-01-01 and 2025-09-30. Analyses will compare subgroups by diagnosis (EO-CRC vs HGIN) and by stage
干预措施: Observational (Retrospective Data Analysis) (Other)
结局指标
主要结局
Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)
时间窗: Baseline - at time of pathological diagnosis (date of pathology report)
Proportion of subjects classified as early stage (high-grade intraepithelial neoplasia \[HGIN\], carcinoma in situ \[Tis\], or T1) versus late stage (T2-T4) at initial pathological diagnosis. Staging is determined from pathology and clinical records using AJCC 8th edition criteria and recorded from the pathology report date. Data source: de-identified electronic medical records, endoscopy reports, and pathology reports. Measurement is categorical (early = 0; late = 1).
次要结局
未报告次要终点
研究者
Run-hua Li
Chief Physician and Master's Supervisor
Shenzhen Hospital of Southern Medical University