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

NCT06868095 | Enrolling By Invitation

• 1 other identifier: ISoPECC Study
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall survival in EOCRC patients

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

• Disease-free survival in EOCRC patients

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

• Prevalence of sarcopenia in EOCRC across different geographic regions

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

• Impact of sarcopenia on post-operative complications.

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

Study Arms (2)

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

Control group

patients \<50 years who had a CT- scan for suspected appendicitis or any other abdominal surgical urgency

Interventions

Surgical resection OTHER

Histologically confirmed EOCRC

Case group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: January 1, 2000
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share