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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Colorectal Cancer; Sarcopenia; Prognostic Factors; Overall Survival; Disease-free Survival; Early Onset Colorectal Cancer
• Intervention / Treatment: Other: Surgical resection

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 Type: Observational
• Enrollment (Estimated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients younger than 50 years old who underwent colorectal cancer resection, with histologically confirmed colorectal cancer (Histologically confirmed EOCRC) and with available baseline CT or MRI scans for sarcopenia assessment

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case group; Patients < 50 years with diagnosis of colorectal cancer and with diagnosis of sarcopenia and CT-based assessment of skeletal muscle mass	Other: Surgical resection; Histologically confirmed EOCRC
Control group; patients <50 years who had a CT- scan for suspected appendicitis or any other abdominal surgical urgency

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival in EOCRC patients	Assessing the overall survival in patients with diagnosis of early-onset colorectal cancer	Patients operated from 2000 to 2024 with at least 3 years follow-up
Disease-free survival in EOCRC patients	Assessing the disease-free survival in patients with diagnosis of early-onset colorectal cancer	Patients operated from 2000 to 2024 with at least 3 years follow-up
Prevalence of sarcopenia in EOCRC across different geographic regions	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	Patients operated from 2000 to 2024 with at least 3 years follow-up
Impact of sarcopenia on post-operative complications.	Investigate how sarcopenia influences post-operative complications	Patients operated from 2000 to 2024 with at least 3 years follow-up

Collaborators and Investigators

• Sponsor: Instituto de Investigación Biomédica de Salamanca

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Muscular Atrophy; Atrophy; Colorectal Neoplasms; Sarcopenia
• Other Study ID Numbers: ISoPECC Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No