NCT07563166Completed
Clinicopathologic Features and Staging Risk Factors of Early-Onset Colorectal Cancer
Clinicopathologic Characteristics and Tumor Staging-Related Risk Factors of Early-Onset Colorectal Cancer: A Retrospective Cohort Study at Shenzhen Hospital, Southern Medical University
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 500 (actual)
- First submitted
- 21 Apr 2026
- Start date
- 30 Jan 2026
- Primary completion date
- 10 Mar 2026
- Lead sponsor
- Run-hua Li
- Diseases
- Colorectal cancer
- NCT number
- NCT07563166
What you commit to
- Study type: Observational
- Participants enrolled: 500
- From 30 Jan 2026 to the primary completion date, 10 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Patients who received initial diagnostic or therapeutic care outside the study site with no accessible pathology or endoscopy reports at Shenzhen Hospital.
Other
- Secondary/metastatic colorectal tumor (colorectal involvement proven to be metastasis from another primary site).
- 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).
Who the study is looking for
- 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).
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shenzhen Hospital of Southern Medical University Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.