Improved screening of esophageal cancer by optical detection of field cancerization.

Phase 2

Completed

• Conditions: 1. Malignant cells in Barretts esophagus. 2. Field carcinogenesis.; 10017990; 10017991

• Registration Number: NL-OMON43548
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

- Patients referred for endoscopic treatment of early neoplasia in a Barrett*s esophagus or patients undergoing standard endoscopic surveillance for non-dysplastic Barrett*s esophagus.
- Age > 18 years.
- Signed informed consent.

Exclusion Criteria

- Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices).
- Presence of an advanced lesion (e.g. type 0-I or type 0-III) not amendable for endoscopic resection (T1b).
- Presence of erosive esophagitis (Los Angeles classification >=A).
- Unable to provide signed informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Differences between in-vivo ESS data from neoplastic areas and<br /><br>non-neoplastic areas.<br /><br>2. Differences between in-vivo ESS data from normal areas of patients with<br /><br>neoplasia vs. normal areas from patients without neoplasia.<br /><br>3. Comparison of in-vivo ESS data with structural information from OCT-images<br /><br>and the attenuation coefficient (µoct).<br /><br>4. Comparison of in-vivo MDSFR spectroscopic data with genetic abnormalities<br /><br>and clonal diversity detected with brush cytology and DNA FISH.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n.v.t.</p><br>