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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43548

Enrollment

Registered

2016-02-24

Start date

2016-04-04

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

1. Malignant cells in Barretts esophagus. 2. Field carcinogenesis.

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
n.v.t.	—

Countries

Netherlands

Outcome results