Sarcopenia Risk Screening in Patients With Gastrointestinal Cancer Using SARC-F

NCT07405307 | Recruiting

• 1 other identifier: OIL-SARC-2023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is a syndrome characterized by progressive loss of skeletal muscle mass and strength and is associated with worse outcomes in cancer patients. It can negatively affect prognosis, increase postoperative complications, reduce tolerance to systemic therapy, and impair quality of life. Sarcopenia may be present even in patients with preserved nutritional status or overweight. This study aims to evaluate the proportion of patients with gastrointestinal cancer who are at risk of sarcopenia, as assessed by the SARC-F screening questionnaire, before initiation of systemic treatment and during treatment. Patients with a positive screening result may be referred for further nutritional evaluation and assessment of sarcopenia severity using anthropometric measurements and DXA, according to standard clinical practice.

Conditions

Gastrointestinal Cancer; Sarcopenia

Keywords

SARC-F; sarcopenia screening; muscle mass loss

Outcome Measures

Primary Outcomes (1)

• Proportion of gastrointestinal cancer patients with positive SARC-F screening

  Percentage of patients with gastrointestinal cancer who screen positive for sarcopenia risk using the SARC-F questionnaire. A SARC-F score ≥4 will be considered positive.

  Baseline (before start of systemic treatment) and during systemic treatment (after 3 months

Study Arms (1)

Gastrointestinal Cancer Patients

Patients with gastrointestinal cancer receiving systemic treatment (adjuvant or metastatic setting) at the Institute of Oncology Ljubljana. Participants will be screened for sarcopenia risk using the SARC-F questionnaire at baseline and during treatment.

Other: Sarcopenia Screening and Nutritional Referral

Interventions

Sarcopenia Screening and Nutritional Referral OTHER

Participants with a positive SARC-F screening result will be referred to the Clinical Nutrition Outpatient Clinic for further assessment of sarcopenia using anthropometric measurements and DXA, and for implementation of multidisciplinary interventions according to standard clinical practice.

Gastrointestinal Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with gastrointestinal cancers treated at the Institute of Oncology Ljubljana, receiving systemic therapy either in the adjuvant setting or for metastatic disease. Patients will be screened for sarcopenia risk using the SARC-F questionnaire before treatment initiation and during systemic therapy.

You may qualify if:

• Adult patients (≥18 years) with gastrointestinal cancer
• Patients planned for or receiving systemic anticancer treatment (adjuvant treatment or treatment of metastatic disease)
• Ability to complete the SARC-F screening questionnaire
• Written informed consent provided

You may not qualify if:

• Patients younger than 18 years
• Patients unable to complete the questionnaire (e.g., severe cognitive impairment or inability to cooperate)
• Patients not eligible for systemic anticancer treatment
• Refusal to participate in the study

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Klavdija Korošec

CONTACT

+386 31630065; kkorosec@onko-i.si

Neža Gros

CONTACT

ngros@onko-i.si

Study Design

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

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 12, 2026
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)