Molecular Assessment for Gastro-Esophageal Cancer

KU Leuven1,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

1,000

Conditions

Esophageal Cancer Gastric Cancer Barrett Esophagus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

Assessment of percentage change of therapy response

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

Time frame: year 2-5

Assessment of incidence of recurrence

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

Time frame: year 2-5

Molecular Assessment for Gastro-Esophageal Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts