- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06346080
Molecular Analysis for Gastro-Esophageal Cancer: Multicenter Discrete Choice Experiment (MAGECmultiDiCE)
The goal of this survey is to investigate the participants' preference for a specific screening/diagnostic tool to detect and assess gastro-esophageal cancer.
The main question it aims to answer are:
- Which diagnostic modality is preferred by patients and the general population?
- Which features of the diagnostic test are most detrimental in the decision-making for one or the other modality?
- Are geographical differences present in regard to the preference for a diagnostic modality?
Participants will be asked to complete a survey of 20-25min, including a brief intake regarding their socio-economic status. This approach will allow us to correct for confounding factors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stijn Vanstraelen, MD
- Phone Number: 0032 16346822
- Email: stijn.vanstraelen@kuleuven.be
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- University Hospitals Leuven
-
Contact:
- Stijn Vanstraelen, MD
- Phone Number: 0032 16347863
- Email: stijn.vanstraelen@kuleuven.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals >18yo to 75yo (upper age limit of Barrett's surveillance)
- Access to computer or smartphone
- Clear understanding of available languages of the experiment (English, French, Dutch, Spanish, German, Chinese, Japanese)
Exclusion Criteria:
- Individuals less than 18yo and more than 75yo
- Incarcerated individuals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Survey participants
Participants who will complete a survey investigating their preference for diagnosis and assessment of gastro-esophageal cancer
|
Discrete choice survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of contribution of diagnostic features to the preference of participants
Time Frame: 2 years
|
A part-worth analysis, expressed as percentage, from a discrete choice experiment (questionnaire) will assess the features that are most important to the participants
|
2 years
|
|
The percentage differences in preference of participants between geographical regions
Time Frame: 2 years
|
Differences in preferences will be compared between different geographical regions using chi-squared or McNemar's test
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the rate patient-level demographics influence the importance of a test feature, expressed as an odds ratio
Time Frame: 2 years
|
Assess the influence of demographic characteristics on the decision-making process using a multivariable logistic regression model, providing odds ratios.
|
2 years
|
|
Assess the rate of trade-off demonstrated as odds ratio between cancer-related mortality reduction and costs
Time Frame: 2 years
|
Based on an anticipated cancer detection and cost, we will assess the willingness-to-pay using a multivariable logistic regression, providing odds ratios.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stijn Vanstraelen, MD, UZ Leuven
- Principal Investigator: Philippe Nafteux, MD, PhD, UZ Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Stomach Neoplasms
- Esophageal Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- s68670
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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