Molecular Assessment for Gastro-Esophageal Cancer

Gastric Cancer Clinical Trial

— MAGEC  

Official title:

Molecular Assessment for Gastro-Esophageal Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346054
• Other study ID #: s68669
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2029

Study information

• Verified date: March 2024
• Source: KU Leuven
• Contact: Stijn Vanstraelen, MD
• Phone: 16346822
• Email: stijn.vanstraelen[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 1, 2029
• Est. primary completion date: July 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer

Intervention

Diagnostic Test:
• Breath analysis
Detection of proteins and volatile organic compounds (oncometabolites) in the exhaled breath
• Blood analysis
Detection of proteins and circulating tumor DNA (oncometabolites) in the peripheral blood

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	year 2-5
Secondary	Assessment of incidence of therapy response	Predict and assess therapy response prior to surgery, based on sensitivity, specificity and accuracy of the oncometabolite concentration	year 2-5
Secondary	Assessment of percentage change of therapy response	Assess changes in the concentrations of the oncometabolites related to treatment.	year 2-5
Secondary	Assessment of incidence of recurrence	Predict and assess recurrence, based on sensitivity, specificity and accuracy of the oncometabolite concentration	year 2-5