Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06868095

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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Colorectal Cancer Atrophy Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease-Free Survival Early Onset Colorectal Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Overall Survival Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prognostic Factors Rectal Diseases Sarcopenia Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical Resection

Other

Histologically confirmed EOCRC

Primary outcomes

  1. Impact of sarcopenia on the incidence of EOCRC

    Time frame: 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 outcomes

  1. Overall survival in EOCRC patients

    Time frame: 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

  2. Disease-free survival in EOCRC patients

    Time frame: 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

  3. Prevalence of sarcopenia in EOCRC across different geographic regions

    Time frame: 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

  4. Impact of sarcopenia on post-operative complications.

    Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up

    Investigate how sarcopenia influences post-operative complications

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Biomédica de Salamanca

Other

Registry information

Official study title

Multi-Center Retrospective Study to Evaluate the Impact of Sarcopenia in Patients with Early-Onset Colorectal Cancer: Incidence Risk Factor or Negative Prognosis Predictor?

Acronym: ISoPECC

Important dates

Study start
2000
Primary completion
2024
Study completion
2025
First posted
Mar 10, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.