Clinical trial NCT04114006: Novel Screening Modality for Early Gastric Cancer
Official title: Initial Analysis of Wide-area Transepithelial Sampling for the Detection of Gastric Neoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: gastric intestinal metaplasia
gastric neoplasia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with indications for upper endoscopy (e.g. dyspepsia)

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic yield of the WATS approach versus standard gastric biopsy mapping
timeFrame: 1-3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Rosa De Copán
country: Honduras
facility: Hospital de Occidente
state: Copan
Study officials:
affiliation: University of Alabama at Birmingham
name: Douglas Morgan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Occidente Honduras
name: Ricardo Dominguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vennalaganti PR, Kaul V, Wang KK, Falk GW, Shaheen NJ, Infantolino A, Johnson DA, Eisen G, Gerson LB, Smith MS, Iyer PG, Lightdale CJ, Schnoll-Sussman F, Gupta N, Gross SA, Abrams J, Haber GB, Chuttani R, Pleskow DK, Kothari S, Goldblum JR, Zhang Y, Sharma P. Increased detection of Barrett's esophagus-associated neoplasia using wide-area trans-epithelial sampling: a multicenter, prospective, randomized trial. Gastrointest Endosc. 2018 Feb;87(2):348-355. doi: 10.1016/j.gie.2017.07.039. Epub 2017 Jul 27.
citation: ASGE STANDARDS OF PRACTICE COMMITTEE; Qumseya B, Sultan S, Bain P, Jamil L, Jacobson B, Anandasabapathy S, Agrawal D, Buxbaum JL, Fishman DS, Gurudu SR, Jue TL, Kripalani S, Lee JK, Khashab MA, Naveed M, Thosani NC, Yang J, DeWitt J, Wani S; ASGE Standards of Practice Committee Chair. ASGE guideline on screening and surveillance of Barrett's esophagus. Gastrointest Endosc. 2019 Sep;90(3):335-359.e2. doi: 10.1016/j.gie.2019.05.012. No abstract available.
citation: Banks M, Graham D, Jansen M, Gotoda T, Coda S, di Pietro M, Uedo N, Bhandari P, Pritchard DM, Kuipers EJ, Rodriguez-Justo M, Novelli MR, Ragunath K, Shepherd N, Dinis-Ribeiro M. British Society of Gastroenterology guidelines on the diagnosis and management of patients at risk of gastric adenocarcinoma. Gut. 2019 Sep;68(9):1545-1575. doi: 10.1136/gutjnl-2018-318126. Epub 2019 Jul 5.