Molecular Assessment for Gastro-Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; Gastric Cancer; Barrett Esophagus

• Registration Number: NCT06346054
• Lead Sponsor: KU Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-3-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Voluntary written informed consent of the participant or their legally authorized<br> representative has been obtained prior to any breath or blood analysis<br><br> 2. >18 years old<br><br> 3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV<br><br> 4. Voluntary healthy controls<br><br>Exclusion Criteria:<br><br> 1. <18 years old<br><br> 2. Patient has history of:<br><br> 1. Active other cancer than gastro-esophageal cancer<br><br> 2. Prior cancer treated <3 years ago<br><br> 3. Hepatic dysfunction/liver failure (MELT >7)<br><br> 3. Any disorder, which in the investigator's opinion might jeopardise participant's<br> safety or compliance with the study plan.<br><br> 4. Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample<br> (e.g., haemolytic sample)<br><br> 5. Incarcerated individuals

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of the concentrations of oncometabolites

Secondary Outcome Measures

Name	Time	Method
Assessment of incidence of early-stage cancer;Assessment of incidence of therapy response;Assessment of percentage change of therapy response;Assessment of incidence of recurrence