Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.

• Conditions: Colorectal Cancer; Prognostic Factors; Overall Survival; Early Onset Colorectal Cancer; Sarcopenia; Disease-free Survival

• Registration Number: NCT06868095
• Lead Sponsor: Instituto de Investigación Biomédica de Salamanca

Brief Summary

Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, has not yet been investigated according to recent literature.

Understanding the prevalence and prognostic impact of sarcopenia in EOCRC could inform tailored therapeutic approaches and improve patient outcomes.

Detailed Description

As reported by the GLOBOCAN study, EOCRC occurs in individuals younger than 50 years old. According to the GLOBOCAN estimates, there were 188,069 new cases of EOCRC, with an Age Standardized Incidence Rate (ASRs) of 2.9 per 100,000 person-years worldwide. Recent evidence suggested an increasing incidence rate for EOCRC in different populations, with greater changes in both developed and developing countries. Despite the declining trend in the incidence of CRC in the total population of the developed countries, the incidence rates for EOCRC were increasing both in the developed and developing world. Sarcopenia's role in early-onset colorectal cancer (EOCRC), a subtype increasingly diagnosed in individuals under 50 years, remains underexplored.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-09
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-12
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Histologically confirmed EOCRC
• Emergency room access for suspected surgical pathology
• Age: 18-49 years at diagnosis.
• Available baseline CT or MRI scans for sarcopenia assessment

Exclusion Criteria

• Presence of comorbidity conditions severely affecting muscle mass unrelated to cancer (e.g., neuromuscular disorders).
• Inadequate follow-up data or loss to follow-up
• No past oncological history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact of sarcopenia on the incidence of EOCRC	Patients operated from 2000 to 2024 with at least 3 years follow-up	Evaluation of sarcopenia on the incidence of early-onset colorectal cancer

Secondary Outcome Measures

Name	Time	Method
Overall survival in EOCRC patients	Patients operated from 2000 to 2024 with at least 3 years follow-up	Assessing the overall survival in patients with diagnosis of early-onset colorectal cancer
Disease-free survival in EOCRC patients	Patients operated from 2000 to 2024 with at least 3 years follow-up	Assessing the disease-free survival in patients with diagnosis of early-onset colorectal cancer
Prevalence of sarcopenia in EOCRC across different geographic regions	Patients operated from 2000 to 2024 with at least 3 years follow-up	Assess the prevalence of sarcopenia in patients with diagnosis of early-onset colorectal cancer according to different geographic regions, hence how different lifestyles and nutritional habits could impact the incidence of sarcopenia
Impact of sarcopenia on post-operative complications.	Patients operated from 2000 to 2024 with at least 3 years follow-up	Investigate how sarcopenia influences post-operative complications