Esophageal CancerNCT06419244
Myosteatosis in Oeso-gastric Cancer: Clinical Impacts
A study testing Myosteatosis in people with Esophageal Cancer and Gastric Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, Myopenia
- What is being tested?
- Myosteatosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Neuromuscular or orthopedic pathology
- Cognitive disorders
- Psychiatric disorders
- Inability to communicate in French or English
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Yannick Deswysen, MD, 00327642213, yannick.deswysen@saintluc.uclouvain.be
About this study
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.
Read the detailed 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.
- Conditions
- Esophageal Cancer, Gastric Cancer, Myopenia, Adipose Tissue Tumor
- Being tested
- Myosteatosis
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms, Neoplasms, Adipose Tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyosteatosisDiagnostic test
Determination of myosteatosis by imaging
| Study group | Role | What they receive |
|---|---|---|
| Surgical patients | Other | Patients undergoing surgery Receives: Diagnostic Test: Myosteatosis |
| Non surgical patients | Other | Patients not undergoing surgery Receives: Diagnostic Test: Myosteatosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Physical functional status 1
Hand grip test
Measured: Through study completion, an average of 2 years
Physical functional status 2
6 minutes walking test
Measured: Through study completion, an average of 2 years
Physical functional status 3
Chair lift test
Measured: Through study completion, an average of 2 years
Cancer-associated adipocytes
Determining the presence and impact of tumor-associated adipocytes
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 May 2024
- Primary completion1 May 2024
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yannick Deswysen, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419244
- Sponsor's protocol ID
- TuMECA
- Status last verified
- May 2024
- First submitted
- 20 Mar 2024
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myosteatosis in Oeso-gastric Cancer: Clinical Impacts
- ClinicalTrials.gov ID
- NCT06419244
- Acronym / sponsor ID
- TuMECA
- Conditions
- Esophageal Cancer, Gastric Cancer, Myopenia, Adipose Tissue Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical patients | Other | Diagnostic Test: MyosteatosisPatients undergoing surgery |
| Non surgical patients | Other | Diagnostic Test: MyosteatosisPatients not undergoing surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Neuromuscular or orthopedic pathology
- Cognitive disorders
- Psychiatric disorders
- Inability to communicate in French or English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyosteatosisDetermination of myosteatosis by imaging | Diagnostic test | Non surgical patients, Surgical patients |
Primary outcome
Myosteatosis
Time frame: Through study completion, an average of 2 years
Muscle fat infiltration measured by analysis of tissue density based on a CT scan in L3 with the help of body component analysis software
4 secondary outcomes
Physical functional status 1
Time frame: Through study completion, an average of 2 years
Physical functional status 2
Time frame: Through study completion, an average of 2 years
Physical functional status 3
Time frame: Through study completion, an average of 2 years
Cancer-associated adipocytes
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick Deswysen, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosteatosis in people with Esophageal Cancer and Gastric Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yannick Deswysen, MD (00327642213, yannick.deswysen@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myosteatosis (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.