Clinicopathologic Features and Staging Risk Factors of Early-Onset Colorectal Cancer
28 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
500
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Guangdong
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Shenzhen, Guangdong, Porcelana, 518000
- Shenzhen Hospital of Southern Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tumor Stage at Diagnosis (Early: HGIN/Tis/T1 vs Late: T2 and above)
Periodo de tiempo: Baseline - at time of pathological diagnosis (date of pathology report)
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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).
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Baseline - at time of pathological diagnosis (date of pathology report)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de enero de 2026
Finalización primaria (Actual)
10 de marzo de 2026
Finalización del estudio (Actual)
31 de marzo de 2026
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de enero de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NYSZYYEC2025K180R001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .