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Novel Screening Modality for Early Gastric Cancer

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ClinicalTrials.gov Identifier: NCT04114006
Recruitment Status : Not yet recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Douglas Morgan MD, University of Alabama at Birmingham

Brief Summary:
Potential patients will be recruited at participating sites based on routine care with clinical indications for upper endoscopy. After careful review of their inclusion and exclusion criteria, patients will be approached regarding the study and if interested, they will be consented and usual standard of care procedures performed. Patients will undergo their scheduled endoscopy with standard forceps biopsies along with WATS brush samples. Documentation of the consent process and procedure will be done as well as data collection related to this study. All samples including standard of care samples and WATS samples will be sent for histologic analysis.

Condition or disease
Gastric Cancer

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Analysis of Wide-area Transepithelial Sampling (WATS) With 3-dimensional Computer Assisted Analysis for the Detection of Gastric Neoplasia
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer




Primary Outcome Measures :
  1. Diagnostic yield of the WATS approach versus standard gastric biopsy mapping [ Time Frame: 1-2 Years ]
    To compare the diagnostic yield of the WATS approach versus standard gastric biopsy mapping (per the updated Sydney system).


Biospecimen Description:
Tissue biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with indications for upper endoscopy (e.g. dyspepsia)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114006


Contacts
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Contact: Tatiana Torres Herman, MD, MHS 205-934-1015 ttherman@uabmc.edu

Locations
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Honduras
Hospital de Occidente Recruiting
Santa Rosa De Copán, Copan, Honduras, 41101
Contact: Ricardo Dominguez, MD    504-9566-0258    ricardod@camo.org   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Douglas Morgan, MD, MPH University of Alabama at Birmingham
Principal Investigator: Ricardo Dominguez, MD Hospital de Occidente Honduras

Publications:
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Responsible Party: Douglas Morgan MD, Professor of Medicine, Director, Division of Gastroenterology/ Hepatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04114006     History of Changes
Other Study ID Numbers: IRB00001470
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Douglas Morgan MD, University of Alabama at Birmingham:
gastric intestinal metaplasia
gastric neoplasia
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases