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The purpose of this study is to create a registry of participants with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with atrophic gastritis, intestinal metaplasia, and dysplasia | Participants with presence of atrophic gastritis, intestinal metaplasia, and dysplasia and risk of the progression of these lesions |
| |
| Control Group | Healthy controls |
| |
| Participants with gastric cancer | Participants with gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | The questionnaire on clinical, environmental, lifestyle, and dietary risk factors will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Creation of participant registry | The primary objective of this study is to create a registry of individuals with precursor lesions for gastric cancer, including gastric atrophy, intestinal metaplasia, and dysplasia. Normal controls and individuals with gastric cancer for comparison of baseline characteristics will also be enrolled. | Up to 10 years |
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Inclusion Criteria:
Age ≥ 18 years old
Able to read and understand English and Spanish
Meet criteria for one of three potentially eligible study populations:
Exclusion Criteria:
Age < 18 years old
Women who are pregnant (may be enrolled after delivery)
Individuals with a prior history of upper gastrointestinal surgery or a prior cancer who are undergoing active treatment for malignancy or have been diagnosed within 1 year prior to the study enrollment or with pancreatic cancer. (This does not include incidentally diagnosed primary gastric adenocarcinoma identified during study follow up. Individuals diagnosed with gastric carcinoid limited to the stomach will also be included, given their ongoing parallel risk for gastric adenocarcinoma.)
Have severe comorbidities with expected survival time <2 years or which would prevent them from undergoing routine elective EGD (at the discretion of the patient's provider and the study team)
Individuals having Hereditary Diffuse Gastric Cancer Syndrome, mutations including CDH1 and CTNNA1, or more than one genetic mutation
Exclude high risk esophageal and duodenal lesions including:
Patients with an increased risk for biopsies during EGD, such as those with clotting disorders.
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Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan Kettering (MSK).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Monika Laszkowska, MD | Contact | 212-639-6857 | LaszkowM@mskcc.org | |
| Xiang Shu, PhD | Contact | 646-227-3658 | ShuX@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Monika Laszkowska, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity) | Recruiting | Commack | New York | 11725 | United States |
|
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All protocol activites) | Recruiting | New York | New York | 10065 | United States |
|
| Memorial Sloan Kettering Nassau (Limited Protocol Activites) | Recruiting | Rockville Centre | New York | 11553 | United States |
|
| ID | Term |
|---|---|
| D005757 | Gastritis, Atrophic |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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