Menu
Enrolling by invitation NCT06868095

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

Observational Colorectal Cancer Early Onset Colorectal Cancer Sarcopenia Prognostic Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgical resection.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Early Onset Colorectal Cancer, Sarcopenia, Prognostic Factors. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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?

Overview

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.

Interventions

  • Other Surgical resection
    Histologically confirmed EOCRC

Primary outcome measures

  • Impact of sarcopenia on the incidence of EOCRC [Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up]
Secondary outcome measures (4)
  • Overall survival in EOCRC patients [Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up]
  • Disease-free survival in EOCRC patients [Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up]
  • Prevalence of sarcopenia in EOCRC across different geographic regions [Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up]
  • Impact of sarcopenia on post-operative complications. [Time frame: Patients operated from 2000 to 2024 with at least 3 years follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Weerink LBM, van der Hoorn A, van Leeuwen BL, de Bock GH. Low skeletal muscle mass and postoperative morbidity in surgical oncology: a systematic review and meta-analysis. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):636-649. doi: 10.1002/jcsm.12529. Epub 2020 Mar 3. PMID 32125769
  • Peterson SJ, Mozer M. Differentiating Sarcopenia and Cachexia Among Patients With Cancer. Nutr Clin Pract. 2017 Feb;32(1):30-39. doi: 10.1177/0884533616680354. Epub 2016 Dec 15. PMID 28124947
  • Aro R, Makarainen-Uhlback E, Ammala N, Rautio T, Ohtonen P, Saarnio J, Merilainen S. The impact of sarcopenia and myosteatosis on postoperative outcomes and 5-year survival in curatively operated colorectal cancer patients - A retrospective register study. Eur J Surg Oncol. 2020 Sep;46(9):1656-1662. doi: 10.1016/j.ejso.2020.03.206. Epub 2020 Mar 17. PMID 32224072
  • Roshandel G, Ghasemi-Kebria F, Malekzadeh R. Colorectal Cancer: Epidemiology, Risk Factors, and Prevention. Cancers (Basel). 2024 Apr 17;16(8):1530. doi: 10.3390/cancers16081530. PMID 38672612

Identifiers

NCT: NCT06868095 · ISoPECC Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗