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

April 28, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen Hospital of Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Run-hua Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Actual)

March 10, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYSZYYEC2025K180R001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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