Proteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22993

Enrollment

Registered

2012-01-18

Start date

2011-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's esophagus, Barrett's neoplasia, Barrett's cancer, Barrett's dysplasia, proteomics

Interventions

Dysplastic group: Non additional. Non-dysplastic group: Endoscopic resection (ER-cap technique) of non-dysplastic Barrett's esophagus.

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria ‘dysplastic’ group: 1. Scheduled ER for Barrett’s esophagus containing HGD or early cancer; 2. Review of biopsies and histopathology specimens by an expert local pathologist; 3. Written informed consent. Inclusion criteria ‘non-dysplastic’ group: 1. Scheduled surveillance endoscopy for Barrett’s esophagus without dysplasia; 2. No dysplasia in biopsies, or biopsies ‘indefinite for dysplasia’ during at least the last two years; 3. No visible abnormalities in Barrett’s esophagus in the two most recent surveillance endoscopies; 4. Review of biopsies and histopathology specimens by an expert local pathologist; 5. Written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria ‘dysplastic’ group: 1. 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: 1. Patients that are not suitable candidates for ER because of co-morbidity.

Design outcomes

Primary

Measure	Time frame
Identification of peptides and proteins which could indicate presence of early neoplasia in a Barrett's esophagus.	—

Secondary

Measure	Time frame
1. Number of identified proteins per cell-surface area; 2. Differences and similarities between protein profiles of dysplastic vs non-dysplastic ER-samples in: A. Epithelial cells; B. Stromal cells.	—

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)