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Molecular Assessment for Gastro-Esophageal Cancer

ConditionsEsophageal CancerGastric CancerBarrett Esophagus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorKU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

<18 years old

Active other cancer than gastro-esophageal cancer

Prior cancer treated <3 years ago

Hepatic dysfunction/liver failure (MELT >7)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Gastro-esophageal cancer groupExperimental treatment 2 interventions
Group B: Barrett's esophagus groupActive comparator 2 interventions
Group C: Healthy controlsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Identification of the concentrations of oncometabolites

Identify the concentrations of cancer-related metabolites (oncometabolites) in the exhaled breath and blood compared to healthy controls

Time frame
year 1-2

Secondary outcomes

1

Assessment of incidence of early-stage cancer

Distinguish early-stage gastro-oesophageal cancer from Barrett's esophagus and healthy controls based on sensitivity, specificity and accuracy of the oncometabolite concentration

Time frame
year 2-5
2

Assessment of incidence of therapy response

Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration

Time frame
year 2-5
3

Assessment of percentage change of therapy response

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

Time frame
year 2-5
4

Assessment of incidence of recurrence

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

Time frame
year 2-5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Sponsor institution

Source ClinicalTrials.gov
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