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OpenTrials
Completed

NCT Number: NCT04114006

Novel Screening Modality for Early Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Occidente

Santa Rosa de Copán, Copán Department, 41101, Honduras

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Diagnostic yield of the WATS approach versus standard gastric biopsy mapping

    Time frame: 1-3 Years

    To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2019
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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