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NCT Number: NCT06346054

Molecular Assessment for Gastro-Esophageal Cancer

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.

Recruiting

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Key information

Conditions

Esophageal Cancer Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions Stomach Diseases Stomach Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Stijn Vanstraelen, MD

CONTACT

[email protected]

16347863 ext. 0032

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • <18 years old
  • Patient has history of:
  • Active other cancer than gastro-esophageal cancer
  • Prior cancer treated <3 years ago
  • Hepatic dysfunction/liver failure (MELT >7)
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the study plan.
  • Insufficient/unreliable quality of breath (e.g., breath flow) or plasma sample (e.g., haemolytic sample)
  • Incarcerated individuals

Treatment and study plan

Breath analysis

Diagnostic Test

Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath

Blood analysis

Diagnostic Test

Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Assessment of percentage change of therapy response

    Time frame: year 2-5

    Assess changes in the concentrations of the oncometabolites related to treatment.

  4. Assessment of incidence of recurrence

    Time frame: year 2-5

    Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Stijn Vanstraelen, MD

CONTACT

[email protected]

16347863 ext. 0032

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Acronym: MAGEC

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 3, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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