Gastric CancerGAPSNCT04191551
The GAstric Precancerous Conditions Study
An observational study of Gastric Cancer and Intestinal Metaplasia of Gastric Mucosa, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 84 years
- Conditions the study is for
- Gastric Cancer, Intestinal Metaplasia of Gastric Mucosa, Helicobacter Pylori Infection
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 84 years
- All sexes
- Adult, Older adult
Study population: As above
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Robert J Huang, MD, 650-725-0634, rjhuang@stanford.edu
About this study
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).
- Conditions
- Gastric Cancer, Intestinal Metaplasia of Gastric Mucosa, Helicobacter Pylori Infection, Atrophic Gastritis
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Precursor lesions | Subjects with precursor lesions detected on endoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at least 24 months after enrollment
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.
Measured: at least 24 months after enrollment
Development of Dysplasia
The presence or absence of dysplasia will be assessed as an indicator of histologic progression.
Measured: at least 24 months after enrollment
Development of Carcinoma
The presence or absence of carcinoma will be assessed to evaluate disease progression.
Measured: at least 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start30 Jul 2018
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert J Huang, MD, Principal investigator, Stanford UniversityJoo Ha Hwang, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191551
- Sponsor's protocol ID
- IRB-45077
- Other IDs
- NCI-2020-13776
- Acronym
- GAPS
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2019
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GAstric Precancerous Conditions Study
- ClinicalTrials.gov ID
- NCT04191551
- Acronym / sponsor ID
- GAPS / IRB-45077
- Conditions
- Gastric Cancer, Intestinal Metaplasia of Gastric Mucosa, Helicobacter Pylori Infection, Atrophic Gastritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precursor lesions | – | –Subjects with precursor lesions detected on endoscopy. |
Who may qualify
- Ages
- 35 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- As above
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Histologic Progression or Regression Assessed by OLGA Score
Time frame: at least 24 months after enrollment
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.
Histologic Progression or Regression Assessed by OLGIM Score
Time frame: at least 24 months after enrollment
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.
Development of Dysplasia
Time frame: at least 24 months after enrollment
The presence or absence of dysplasia will be assessed as an indicator of histologic progression.
Development of Carcinoma
Time frame: at least 24 months after enrollment
The presence or absence of carcinoma will be assessed to evaluate disease progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert J Huang, MD principal investigator
Stanford University
Joo Ha Hwang, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Intestinal Metaplasia of Gastric Mucosa, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert J Huang, MD (650-725-0634, rjhuang@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histologic Progression or Regression Assessed by OLGA Score (time frame: at least 24 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.