Clinicopathologic Features and Staging Risk Factors of Early-Onset Colorectal Cancer
2026年4月28日 更新者:Run-hua Li
Clinicopathologic Characteristics and Tumor Staging-Related Risk Factors of Early-Onset Colorectal Cancer: A Retrospective Cohort Study at Shenzhen Hospital, Southern Medical University
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.
研究概览
地位
地位
完全的
干预/治疗
干预/治疗
研究类型
研究类型
观察性的
注册 (实际的)
注册
500
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Guangdong
-
Shenzhen、Guangdong、中国、518000
- Shenzhen Hospital of Southern Medical University
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients aged ≤50 years with pathology-confirmed colorectal cancer (any T stage) or high-grade intraepithelial neoplasia (HGIN) diagnosed at Shenzhen Hospital, Southern Medical University between 2016-01-01 and 2025-09-30.
This retrospective single-cohort study uses de-identified electronic medical records, endoscopy, imaging, and pathology reports to extract demographics, clinical presentation, lifestyle and family history, laboratory and tumor markers, endoscopic/imaging features, detailed pathology (location, size, differentiation, TNM/AJCC stage, LVI, molecular markers if available), treatments, and follow-up outcomes.
No additional patient contact or study interventions; data handled under IRB approval/waiver with secure coding and restricted access.
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
团体/队列数
1
队列和干预
团体/队列团体/队列 |
干预/治疗干预/治疗 |
|---|---|
|
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
|
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.
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)
大体时间: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).
|
Baseline - at time of pathological diagnosis (date of pathology report)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
学习开始
2026年1月30日
初级完成 (实际的)
初级完成
2026年3月10日
研究完成 (实际的)
研究完成
2026年3月31日
研究注册日期
首次提交
首次提交
2026年4月21日
首先提交符合 QC 标准的
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
首次发布
2026年5月1日
研究记录更新
最后更新发布 (实际的)
最后更新发布
2026年5月1日
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
2026年4月28日
最后验证
最后验证
2026年1月1日
更多信息
与本研究相关的术语
其他研究编号
其他研究编号
- NYSZYYEC2025K180R001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.