## Protocol Section
### Identification Module
**NCT ID:** NCT06419244

**Brief Title:** Myosteatosis in Oeso-gastric Cancer: Clinical Impacts

**Official Title:** Myosteatosis in Oeso-gastric Cancer: Clinical Impacts

#### Organization Study ID Info
**ID:** TuMECA
#### Organization
**Class:** OTHER
**Full Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain
### Status Module
#### Completion Date
**Date:** 2026-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2024-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-20
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cliniques universitaires Saint-Luc- Université Catholique de Louvain

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Esophageal Cancer

- Gastric Cancer

- Myopenia

- Adipose Tissue Tumor

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients undergoing surgery

**Intervention Names:**

- Diagnostic Test: Myosteatosis

**Label:** Surgical patients

**Type:** OTHER

#### Arm Group 2

**Description:** Patients not undergoing surgery

**Intervention Names:**

- Diagnostic Test: Myosteatosis

**Label:** Non surgical patients

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Non surgical patients

- Surgical patients

**Description:** Determination of myosteatosis by imaging

**Name:** Myosteatosis

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Muscle fat infiltration measured by analysis of tissue density based on a CT scan in L3 with the help of body component analysis software

**Measure:** Myosteatosis

**Time Frame:** Through study completion, an average of 2 years

#### Secondary Outcomes

**Description:** Hand grip test

**Measure:** Physical functional status 1

**Time Frame:** Through study completion, an average of 2 years

**Description:** 6 minutes walking test

**Measure:** Physical functional status 2

**Time Frame:** Through study completion, an average of 2 years

**Description:** Chair lift test

**Measure:** Physical functional status 3

**Time Frame:** Through study completion, an average of 2 years

**Description:** Determining the presence and impact of tumor-associated adipocytes

**Measure:** Cancer-associated adipocytes

**Time Frame:** Through study completion, an average of 2 years

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yannick.deswysen@saintluc.uclouvain.be

**Name:** Yannick Deswysen, MD

**Phone:** 00327642213

**Role:** CONTACT

**Contact 2:**

**Email:** nicolas.lanthier@saintluc.uclouvain.be

**Name:** Nicolas Lanthier, PhD

**Phone:** 00327642822

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bruxelles

**Contacts:**

***Contact 1:***

- **Email:** yannick.deswysen@saintluc.uclouvain.be

- **Name:** Yannick Deswysen, MD

- **Phone:** 00327642213

- **Role:** CONTACT

**Country:** Belgium

**Facility:** Cliniques universitaires Saint-Luc

**Status:** RECRUITING

**Zip:** 1200

#### Overall Officials

**Official 1:**

**Affiliation:** Cliniques universitaires Saint-Luc

**Name:** Yannick Deswysen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000013272

- Term: Stomach Diseases

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: M8088

- Name: Esophageal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M20351

- Name: Neoplasms, Adipose Tissue

- Relevance: HIGH

- As Found: Adipose Tissue Tumor

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16062

- Name: Stomach Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: HIGH

- As Found: Gastric Cancer

- ID: T2141

- Name: Esophageal Cancer

- Relevance: HIGH

- As Found: Esophageal Cancer

### Condition Browse Module - Meshes

- ID: D000013274

- Term: Stomach Neoplasms

- ID: D000018205

- Term: Neoplasms, Adipose Tissue

### Misc Info Module

- Version Holder: 2024-05-31
