Molecular Assessment for Gastro-Esophageal Cancer

NCT06346054 | Recruiting DMC

• 1 other identifier: s68669
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Gastric Cancer; Barrett Esophagus

Keywords

Oncometabolites; Early-stage cancer; Diagnostic testing; Screening

Outcome Measures

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

  year 1-2

Secondary Outcomes (4)

• Assessment of incidence of early-stage cancer

  year 2-5

• Assessment of incidence of therapy response

  year 2-5

• Assessment of percentage change of therapy response

  year 2-5

• Assessment of incidence of recurrence

  year 2-5

Study Arms (3)

Gastro-esophageal cancer group

EXPERIMENTAL

Participants with gastroesophageal cancer providing a breath and blood sample for biomarker identification

Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis

Barrett's esophagus group

ACTIVE COMPARATOR

Participants with Barrett's esophagus providing a breath and blood sample for biomarker identification

Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis

Healthy controls

ACTIVE COMPARATOR

Healthy controls providing a breath and blood sample for biomarker identification

Diagnostic Test: Breath analysis; Diagnostic Test: Blood analysis

Interventions

Breath analysis DIAGNOSTIC_TEST

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

Barrett's esophagus group; Gastro-esophageal cancer group; Healthy controls

Blood analysis DIAGNOSTIC_TEST

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

Barrett's esophagus group; Gastro-esophageal cancer group; Healthy controls

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Barrett Esophagus; Neoplasms

Interventions

Breath Tests; Hematologic Tests

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques

Study Officials

• Stijn Vanstraelen, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Philippe Nafteux, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stijn Vanstraelen, MD

CONTACT

16347863; stijn.vanstraelen@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants with gastro-esophageal cancer, participants with Barrett's esophagus and Healthy controls will be monitored in parallel to identify oncometabolic biomarkers related to cancer

Study Record Dates

• First Submitted: March 23, 2024
• First Posted: April 3, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

BE (1)