Clinical trial NCT06868095: Multi-Center Study Protocol: Impact of Sarcopenia in Early-Onset Colorectal Cancer.
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?
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer
Early Onset Colorectal Cancer
Sarcopenia
Prognostic Factors
Overall Survival
Disease-free Survival
Lead sponsor: Instituto de Investigación Biomédica de Salamanca
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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

Primary outcomes:
measure: Impact of sarcopenia on the incidence of EOCRC
timeFrame: Patients operated from 2000 to 2024 with at least 3 years follow-up
Secondary outcomes:
measure: Overall survival in EOCRC patients
timeFrame: Patients operated from 2000 to 2024 with at least 3 years follow-up
measure: Disease-free survival in EOCRC patients
timeFrame: Patients operated from 2000 to 2024 with at least 3 years follow-up
measure: Prevalence of sarcopenia in EOCRC across different geographic regions
timeFrame: Patients operated from 2000 to 2024 with at least 3 years follow-up
measure: Impact of sarcopenia on post-operative complications.
timeFrame: Patients operated from 2000 to 2024 with at least 3 years follow-up
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.