Risk Assessment Evaluation for Identifying Participants at High Risk for Stomach Cancer

Официальное название

OUR Stomach Health Project: A Pilot Study to Evaluate the Feasibility of Stomach Cancer Risk Assessment for Early Detection and Secondary Prevention

Обзор

This clinical trial evaluates the usefulness of various risk assessment tests, including Helicobacter pylori (H. pylori) breath testing, questionnaires, and endoscopies for identifying participants at high risk for stomach cancer. H. pylori is a bacteria that causes stomach inflammation and ulcers in the stomach. People with H. pylori infections may be more likely to develop cancer in the stomach. H. pylori breath testing can help identify the presence of H. pylori infection in a participant and help identify if the participant may be at a higher risk of developing stomach cancer. An endoscopy uses a thin, flexible lighted tube that is inserted inside the esophagus, stomach, and first part of the small intestine. This allows the doctor to see and look for abnormal areas that may need to be biopsied. Risk assessment including H. pylori evaluation, questionnaires, and endoscopies may help identify participants at high risk for stomach cancer and may be a useful screening tool for earlier stomach cancer diagnosis.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the feasibility of using community outreach and clinical assessment to identify persons at high risk for gastric cancer.

SECONDARY OBJECTIVES:

I. To determine the presence of gastric cancer (GC) associated risk factors amongst the diverse ethnic populations (in greater Orange and Los Angeles Counties).

II. To determine the proportion of high-risk patients who are willing to undergo upper endoscopy.

III. To identify actionable diagnoses on upper endoscopy of high-risk individuals.

EXPLORATORY OBJECTIVE:

I. To assess population-based understanding of gastric cancer.

OUTLINE:

PART I: Participants complete questionnaires, undergo collection of a blood sample, and undergo an H. pylori breath test for gastric cancer risk assessment at baseline.

PART II: High-risk participants are assigned to cohort I and non-high risk participants are assigned to cohort II.

COHORT I: Participants may undergo esophagogastroduodenoscopy (EGD) with possible tissue biopsy within 3 months of baseline risk assessment and complete questionnaires annually up to 3 years.

COHORT II: Participants complete questionnaires for re-assessment annually up to 3 years and may undergo EGD at year 2.

Participants are followed up annually for a total of 3 years.

Вмешательства

• Процедура Biopsy
  Undergo tissue biopsy
• Процедура Biospecimen Collection
  Undergo blood sample collection
• Процедура Breath Test
  Undergo H. pylori breath test
• Процедура Esophagogastroduodenoscopy
  Undergo EGD
• Другое Questionnaire Administration
  Complete questionnaires

Первичные конечные точки

• Percentage of screening individuals found to be at high risk for gastric cancer (feasibility) [Срок оценки: At time of screening up to 3 years]

Критерии участия

Критерии включения

• Documented informed consent of the participant and/or legally authorized representative

• Assent, when appropriate, will be obtained per institutional guidelines
• Age: ≥ 40 years to ≤ 80 years
• Identify as a racial minority either Asian, Hispanic, or Black American
• Willingness to:

• Provide blood samples and undergo upper endoscopy

Критерии исключения

• Identify as Non-Hispanic White
• History of gastric cancer
• Known premalignant lesions of the stomach
• History of upper endoscopy within 2 years
• Women of childbearing potential: Pregnant/ nursing
• An employee who is under the direct/indirect supervision of the principal investigator (PI)/a coinvestigator/the study manager
• A direct study team member

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• City of Hope Medical Center — Duarte

Идентификаторы

NCT: NCT06408220 · 23379 · NCI-2024-03206 · 23379 · P30CA033572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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