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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06419244
Other study ID # TuMECA
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date May 31, 2026

Study information

Verified date May 2024
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Yannick Deswysen, MD
Phone 00327642213
Email yannick.deswysen@saintluc.uclouvain.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this project is to study the presence of cancer-associated adipocytes in oesogastric cancers and their possible links with myosteatosis. This research project has a retrospective component, the aim of which is to analyse the body component based on imaging in patients with oesogastric neoplasia in order to determine the incidence of myosteatosis and to study the relationship with oncological and prognostic data. The second part of the project is prospective and will collect biological material (skeletal muscle, adipose tissue, tumour, blood) for histological, molecular and genomic analyses and will analyse muscle function in patients with oesogastric cancer. It will address the role of adipocytes in the tumour microenvironment of oesogastric cancer, focusing on their interactions with the observed muscle myosteatosis and prognosis. In the future, it will help to identify signalling pathways, targets and patients who could benefit from appropriate treatment.


Description:

Oesophageal and gastric cancer pose a significant challenge to caregivers, both in terms of the complexity of its presentation and its treatment. At diagnosis, patients often present with malnutrition associated with sarcopenia, which has a significant impact on morbidity and mortality. Although loss of muscle mass has received much attention in cancer, muscle quality, particularly the accumulation of fat in muscle named "myosteatosis", may be considered as a better predictor of a patient's physical condition and ability to recover from cancer treatments. Studying the tumor microenvironment is essential to understanding the mechanisms underlying disease progression. Cancer-associated adipocytes (CAA), a major component of this tumor microenvironment, provide an interface for dialogue with the tumor through the secretion of pro-inflammatory cytokines, metalloproteases and the release of free fatty acids. They have been described as capable of stimulating tumor progression, particularly in breast cancer. However, their presence in oesogastric cancer and possible links with myosteatosis have not been described.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 31, 2026
Est. primary completion date May 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with cancer of the oesophagus, oeso-gastric junction or stomach - Treatment and estimated survival of more than 3 months - Signed informed consent - > 18 years of age Exclusion Criteria: - Neuromuscular or orthopedic pathology - Cognitive disorders - Psychiatric disorders - Inability to communicate in French or English

Study Design


Intervention

Diagnostic Test:
Myosteatosis
Determination of myosteatosis by imaging

Locations

Country Name City State
Belgium Cliniques universitaires Saint-Luc Bruxelles

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myosteatosis Muscle fat infiltration measured by analysis of tissue density based on a CT scan in L3 with the help of body component analysis software Through study completion, an average of 2 years
Secondary Physical functional status 1 Hand grip test Through study completion, an average of 2 years
Secondary Physical functional status 2 6 minutes walking test Through study completion, an average of 2 years
Secondary Physical functional status 3 Chair lift test Through study completion, an average of 2 years
Secondary Cancer-associated adipocytes Determining the presence and impact of tumor-associated adipocytes Through study completion, an average of 2 years
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