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

NCT07563166 | Completed

• 1 other identifier: NYSZYYEC2025K180R001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasms; High Grade Intraepithelial Neoplasia

Keywords

High-Grade Intraepithelial Neoplasia (HGIN); Early-Onset Colorectal Cancer (EO-CRC)

Outcome Measures

Primary Outcomes (1)

• Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)

  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)

Study Arms (1)

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)

Interventions

Observational (Retrospective Data Analysis) OTHER

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.

Single Retrospective Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Run-hua Li: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

Location

Related Publications (1)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician and Master's Supervisor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start: January 30, 2026
• Primary Completion: March 10, 2026
• Study Completion: March 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)