The GAstric Precancerous Conditions Study (GAPS)
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|ClinicalTrials.gov Identifier: NCT04191551|
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : March 17, 2021
Gastric cancer afflicts 27,000 Americans annually and carries a dismal prognosis. One reason for poor outcomes is late diagnosis, as the majority of gastric cancers in the United States are diagnosed at a relatively advanced stage where curative resection is unlikely. Gastric intestinal metaplasia (GIM) is a precancerous change of the stomach which increases risk for subsequent gastric cancer multiple-fold.
The Gastric Precancerous Conditions Study (GAPS) is an observational study with two over-arching objectives: 1) improve the non-invasive identification of patients with GIM, and 2) develop biological markers to predict the subset of GIM which will progress onto gastric cancer.
To achieve Aim 1, a case-control study (N=300 pairs) matching cases of GIM with age-/gender-matched controls will be recruited form the population of subjects undergoing clinically-indicated endoscopy. Determination of gastric pathology will be made by two, independent gastrointestinal pathologists. At time of endoscopy, a detailed clinical questionnaire is administered by face-to-face interview. Saliva and blood is collected prior to endoscopy. At time of endoscopy, protocoled clinical biopsies (per Revised Sydney Protocol) as well as additional research specimens are collected. Scoring of GIM will be performed based on the Operative Link for GIM scoring system.
To achieve Aim 2, patients with histologically-confirmed GIM (N=300) will be followed longitudinally. Biennial endoscopic surveillance will be performed, with repeat biopsies, specimen collection, and histologic scoring. Progression of GIM will be defined as upstaging of GIM score, or development of either dysplasia or carcinoma on any biopsy.
|Condition or disease|
|Gastric Cancer Intestinal Metaplasia of Gastric Mucosa Helicobacter Pylori Infection Atrophic Gastritis|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||The GAstric Precancerous Conditions Study|
|Actual Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2024|
Gastric intestinal metaplasia
Subjects with histologically-confirmed intestinal metaplasia found during endoscopy with protocoled biopsies.
Subjects without intestinal metaplasia found during endoscopy with protocoled biopsies (age and sex matched to cases)
- Progression of intestinal metaplasia [ Time Frame: 24 months following enrollment ]Progression will be assessed using the Operative Link for Gastric Intestinal Metaplasia (Reference 1). This score reflects both the histologic severity as well as anatomic location of intestinal metaplasia. Scores range from 0 (no metaplasia) to 4 (severe metaplasia). It is believed that higher scores portend a higher risk for progression to cancer.
Biospecimen Retention: Samples With DNA
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): NCT04191551
|Contact: Robert J Huang, MDfirstname.lastname@example.org|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Robert J Huang, MD 650-725-0634 email@example.com|
|Principal Investigator:||Robert J Huang, MD||Stanford University|
|Principal Investigator:||Joo Ha Hwang, MD, PhD||Stanford University|