Novel Screening Modality for Early Gastric Cancer

Initial Analysis of Wide-area Transepithelial Sampling for the Detection of Gastric Neoplasia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04114006

Enrollment

120

Registered

2019-10-03

Start date

2019-10-01

Completion date

2023-03-15

Last updated

2023-09-11

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

Conditions

Gastric Cancer

Keywords

gastric intestinal metaplasia, gastric neoplasia

Brief summary

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for pathology analysis, per standard clinical practice.

Detailed description

Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. Following informed consent, patients will undergo their scheduled endoscopy with standard forceps biopsies along with the transepithelial brush samples. All samples, biopsy and brush samples, will be sent for histologic analysis, with planned study of the diagnostic yields of each method.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subject is informed of the investigational nature of this study and given verbal and written informed consent in accordance with local, U.S., and international guidelines. * Both males and females at least 18 years. * Patients with clinical indications for upper endoscopy

Exclusion criteria

* Patients should not have an advanced medical or psychiatric conditions which that may limit their ability to participate in the study, as judged by the physician.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic yield of the WATS approach versus standard gastric biopsy mapping	1-3 Years	To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).

Countries

Honduras

Outcome results