The GAstric Precancerous Conditions Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-84
SponsorStanford University

About this trial

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 precursors (such as atrophic gastritis and intestinal metaplasia) are precancerous changes to the stomach mucosa which increases risk for subsequent gastric cancer.

The Gastric Precancerous Conditions Study (GAPS) is an observational study of patients at elevated risk for gastric cancer. Investigators seek to recruit patients from endoscopy unit of Stanford Health Care, a large academic network of hospitals and clinics serving Northern California. Investigators will recruit patients who are both symptomatic (e.g. dyspepsia) and asymptomatic (e.g. referred for screening), and individuals both with known precursor lesions (such as intestinal metaplasia) or at high risk for carrying precursor lesions. A component of the study is long-term follow-up of individuals with gastric precursors. This is to understand their risk factors for histologic progression and regression. During both index and subsequent endoscopies, the study team will collect biospecimens (e.g. blood, saliva, gastric tissue).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Cannot give consent

Have history of gastric surgery

Have history of solid tumor or bone marrow transplant

Platelet Count < 70 or international normalized ratio > 1.5

Trial population

As above

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

600 Participants
are grouped into 1 trial group
Group A: Precursor lesions

Trial outcomes

Primary outcomes

1

Histologic Progression or Regression Assessed by OLGA Score

Histologic progression or regression will be evaluated using the Operative Link on Gastritis Assessment (OLGA) score. This score stages the severity of atrophic gastritis based on histological findings.

Time frame
at least 24 months after enrollment
2

Histologic Progression or Regression Assessed by OLGIM Score

Histologic progression or regression will be assessed using the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) score. This score stages the extent of intestinal metaplasia.

Time frame
at least 24 months after enrollment
3

Development of Dysplasia

The presence or absence of dysplasia will be assessed as an indicator of histologic progression.

Time frame
at least 24 months after enrollment
4

Development of Carcinoma

The presence or absence of carcinoma will be assessed to evaluate disease progression.

Time frame
at least 24 months after enrollment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.