To hear about similar clinical trials, please enter your email below
Trial Title:
Molecular Assessment for Gastro-Esophageal Cancer
NCT ID:
NCT06346054
Condition:
Esophageal Cancer
Gastric Cancer
Barrett Esophagus
Conditions: Official terms:
Esophageal Neoplasms
Barrett Esophagus
Conditions: Keywords:
Oncometabolites
Early-stage cancer
Diagnostic testing
Screening
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
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
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Breath analysis
Description:
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled
breath
Arm group label:
Barrett's esophagus group
Arm group label:
Gastro-esophageal cancer group
Arm group label:
Healthy controls
Intervention type:
Diagnostic Test
Intervention name:
Blood analysis
Description:
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood
Arm group label:
Barrett's esophagus group
Arm group label:
Gastro-esophageal cancer group
Arm group label:
Healthy controls
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University Hospitals Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Stijn Vanstraelen, MD
Phone:
16347863
Phone ext:
0032
Email:
stijn.vanstraelen@kuleuven.be
Start date:
August 1, 2024
Completion date:
July 1, 2029
Lead sponsor:
Agency:
KU Leuven
Agency class:
Other
Source:
KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06346054
