Molecular Assessment for Gastro-Esophageal Cancer (MAGEC)

March 28, 2024 updated by: Stijn Vanstraelen, KU Leuven

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gastro-esophageal cancer group
Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification
Diagnostic test: Breath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
Diagnostic test: Blood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Active Comparator: Barrett's esophagus group
Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification
Diagnostic test: Breath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
Diagnostic test: Blood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Active Comparator: Healthy controls
Healthy controls providing a breath and blood sample for biomarker identification
Diagnostic test: Breath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
Diagnostic test: Blood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the concentrations of oncometabolites
Time Frame: year 1-2
Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls
year 1-2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of incidence of early-stage cancer
Time Frame: 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
year 2-5
Assessment of incidence of therapy response
Time Frame: year 2-5
Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration
year 2-5
Assessment of percentage change of therapy response
Time Frame: year 2-5
Assess changes in the concentrations of the oncometabolites related to treatment.
year 2-5
Assessment of incidence of recurrence
Time Frame: year 2-5
Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration
year 2-5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Investigators

  • Principal Investigator: Stijn Vanstraelen, MD, Universitaire Ziekenhuizen KU Leuven
  • Principal Investigator: Philippe Nafteux, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

March 28, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s68669

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared upon reasonable request with the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Breath analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe