Molecular Assessment for Gastro-Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Barrett Esophagus; Esophageal Cancer; Gastric Cancer
• Interventions: Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis

• Registration Number: NCT06346054
• Lead Sponsor: KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-04-03
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22
• Primary Completion: 2029-07-01
• Study Completion: 2029-07-01

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastro-esophageal cancer group	Blood analysis	Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
Healthy controls	Breath analysis	Healthy controls providing a breath and blood sample for biomarker identification
Healthy controls	Blood analysis	Healthy controls providing a breath and blood sample for biomarker identification
Gastro-esophageal cancer group	Breath analysis	Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
Barrett's esophagus group	Breath analysis	Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
Barrett's esophagus group	Blood analysis	Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification

Primary Outcome Measures

Name	Time	Method
Identification of the concentrations of oncometabolites	year 1-2	Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls

Secondary Outcome Measures

Name	Time	Method
Assessment of incidence of recurrence	year 2-5	Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration
Assessment of incidence of early-stage cancer	year 2-5	Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration
Assessment of incidence of therapy response	year 2-5	Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration
Assessment of percentage change of therapy response	year 2-5	Assess changes in the concentrations of the oncometabolites related to treatment.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium