NCT06419244

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
May 2024May 2026

First Submitted

Initial submission to the registry

March 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

Same day

First QC Date

March 20, 2024

Last Update Submit

May 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Physical functional status 1

    Through study completion, an average of 2 years

  • Physical functional status 2

    Through study completion, an average of 2 years

  • Physical functional status 3

    Through study completion, an average of 2 years

  • Cancer-associated adipocytes

    Through study completion, an average of 2 years

Study Arms (2)

Surgical patients

OTHER

Patients undergoing surgery

Diagnostic Test: Myosteatosis

Non surgical patients

OTHER

Patients not undergoing surgery

Diagnostic Test: Myosteatosis

Interventions

MyosteatosisDIAGNOSTIC_TEST

Determination of myosteatosis by imaging

Non surgical patientsSurgical patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Neuromuscular or orthopedic pathology
  • Cognitive disorders
  • Psychiatric disorders
  • Inability to communicate in French or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsNeoplasms, Adipose Tissue

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Study Officials

  • Yannick Deswysen, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

May 17, 2024

Study Start

May 1, 2024

Primary Completion

May 1, 2024

Study Completion (Estimated)

May 31, 2026

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations