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

NCT ID: NCT06868095

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Case group

Patients \< 50 years with diagnosis of colorectal cancer and with diagnosis of sarcopenia and CT-based assessment of skeletal muscle mass

Surgical resection

Intervention Type OTHER

Histologically confirmed EOCRC

Control group

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

No interventions assigned to this group

Interventions

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Surgical resection

Histologically confirmed EOCRC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 32125769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28124947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32224072 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38672612 (View on PubMed)

Other Identifiers

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ISoPECC Study

Identifier Type: -

Identifier Source: org_study_id

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