Proteomics in Early Neoplasia in Barrett*s Esophagus: Biomarkers for Early Detection.
- Conditions
- Barrett's esophaguscancer1001799010017991
- Registration Number
- NL-OMON36814
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion criteria *dysplastic* group:
- Scheduled ER for Barrett*s esophagus containing HGD or early cancer;
- Review of biopsies and histopathology specimens by an expert local pathologist;
- Written informed consent;Inclusion criteria *non-dysplastic* group:
- Scheduled surveillance endoscopy for Barrett*s esophagus without dysplasia;
- No dysplasia in biopsies, or biopsies *indefinite for dysplasia* during at least the last two years;
- No visible abnormalities in Barrett*s esophagus in the two most recent surveillance endoscopies;
- Review of biopsies and histopathology specimens by an expert local pathologist;
- Written informed consent
Exclusion criteria *dysplastic* group:
- In case histopathological assessment of the frozen half of the ER specimen is necessary for clinical decision making, the specimen will be retrieved from the Barrett*s research tissue bank and further processed for clinical care.;Exclusion criteria *non-dysplastic* group:
- Patients that are not suitable candidates for ER because of co-morbidity;
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Identification of peptides and proteins that may indicate the presence of<br /><br>early neoplasia in Barrett*s.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Number of proteins found per cell surface area;<br /><br>- Differences and similarities in protein profiles of 10 dysplastic versus 10<br /><br>non-dysplastic specimens in 1) epithelial and 2) stromal cells;</p><br>