Molecular Assessment for Gastro-Esophageal Cancer (MAGEC)

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Gastric Cancer; Esophageal Cancer; Barrett Esophagus

Treatments: Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06346054

s68669

Details and patient eligibility

About

The goal of this minimally invasive interventional study is to learn if oncometabolic biomarkers, detected in the exhaled breath and blood can identify early-stage gastro-oesophageal cancer in patient at risk for gastro-oesophageal cancer.

The main questions this study aims to answer:

Are oncometabolites proficient and reproducible enough to function as diagnostic biomarkers? Can these biomarkers identify early-stage gastro-esophageal cancer? Researchers will compare participants with gastro-oesophageal cancer to healthy controls and participants with Barrett's esophagus to detect meaningful differences between the groups.

Participants will provide a breath and blood sample during their routine standard of care visits.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any breath or blood analysis
2. >18 years old
3. Barrett's esophagus or treatment naïve gastro-esophageal cancer stage I to IV
4. Voluntary healthy controls

Exclusion criteria

1. <18 years old

2. Patient has history of:

   1. Active other cancer than gastro-esophageal cancer
   2. Prior cancer treated <3 years ago
   3. Hepatic dysfunction/liver failure (MELT >7)

3. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.

4. Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)

5. Incarcerated individuals

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Gastro-esophageal cancer group

Experimental group

Description:

Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification

Treatment:

Diagnostic Test: Blood analysis

Diagnostic Test: Breath analysis

Barrett's esophagus group

Active Comparator group

Description:

Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification

Treatment:

Diagnostic Test: Blood analysis

Diagnostic Test: Breath analysis

Healthy controls

Active Comparator group

Description:

Healthy controls providing a breath and blood sample for biomarker identification

Treatment:

Diagnostic Test: Blood analysis

Diagnostic Test: Breath analysis