Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Infections

Rare Diseases

Carcinoma

Atrophy

Stomach Neoplasms

Communicable Diseases

Gastritis, Atrophic

Gastritis

Gastroenteritis

Gastrointestinal Diseases

Stomach Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Cancer

Chronic Graft Versus Host Disease

Jian-Kun Hu, M.D. Ph.D.

Jian-Kun Hu

To establish prospective cohort of healthy population and corresponding serum sample bank in Sichuan province to provide platform for exploring early diagnosis and screening strategy of gastric cancer by a prospective cohort study.

H. pylori was one of the most important carcinogenic factor for gastric cancer and play a crucial role in inducing gastritis, atrophy and canceration. Chronic atrophic gastritis (CAG) was a common precancerous disease, people with CAG become high-risk population and need regular follow-up. However, study about occurrence risk prediction for gastric cancer when H. pylori infection concurrence with CAG was still spare. In especial, there was still no population screening program based on serology. The relative clinical epidemiology for providing evidence for China gastric cancer screening program was very rare.

This study aim to evaluate gastric cancer occurrence risk and diagnostic value of people combined with H. pylori infection and CAG by Serological methods in Sichuan province China. We also project to design optimized screening program suitable for people in sichuan province China.

Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)

A Prospective Cohort Study of Early Detection and Screening Strategy for Gatric Cancer in Sichuan Province China (SIGES-01)

The new cases of gastric and other epidermal malignant tumor

The time during SIGES when finding nee gastric cancer and relative disease

Xin-Zu Chen

Vice director of Gastrointestinal Surgery department, West China Hospital; Director of Institute of Gastric Cancer, State Key Laboratory of Biotherapy, West China Hospital

Xiaobo Li, MD.Ph.D

Parts of patients are diagnosed as H. pylori -negative before ER, whereas the specimens become H. pylori-positive after ER, which may have a role in the recurrence of EGC. Our study aims to determine the difference in H. pylori infection rate of EGC patients before and after ER , and discuss the causes leading to the difference, which can provide references for improving the diagnostic accuracy of H. pylori infection and reducing EGC's recurrence rate.

Gastric cancer is the fourth most commonly diagnosed cancer in the world and the second leading cause of cancer-related deaths. Nowadays, endoscopic resection（ER） is widely accepted as the primary treatment for early gastric cancer (EGC) without lymph node metastasis，which includes endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).However, recurrence rate after endoscopic resection for EGC still achieves 6.7%-14%. However, there is no comparative analysis about H. pylori infection rate before and after ER yet.

All the lesions will be removed endoscopically or surgically and examine histologically by an independent gastrointestinal pathologist.

Each biospecimen after ER will be detected H pylori infection status.

Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection

Information on the H pylori infection status before ER will be collected from the medical records of each patient. A positive result on at least one rapid urease test, urease breath test or Giemsa staining is deemed to be indicative of H pylori infection .Each specimen after ER will be detected H pylori infection status in two weeks. Then we analyze the difference in H. pylori infection rate before and after ER.

Shanghai Jiao Tong University School of Medicine

Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Helicobacter Infections

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies;

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability

a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies

Test-and-treat EHR-CHW intervention

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.

Usual care of EHR-only intervention

Simona Kwon, DrPH,MPH

This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, \> 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.

Patient-Centered Cancer Prevention In Chinese Americans

Measured using breath ammonia measurement, fecal stool antigen test or other clinically approved H. pylori infection diagnostic test. Data extracted from patient EHR.

11- item assessment of participant's confidence in making an informed choice. For each item, confidence is rated on a 5-point Likert scale from 0 (not at all confident) to 4 (very confident). The total score is the sum of responses and ranges from 0 to 44; higher scores indicate greater decision self-efficacy.

"The MARS-5 is a 5-item self-assessment of medication adherence. The first item assesses unintentional non-adherence, while the four other items assess intentional non-adherence. Participants indicated how often each statement applied to them in the past month on a 5-point Likert scale (1=always, 2=often, 3=sometimes, 4=rarely, 5=never), resulting in a total score ranging from 5 to 25. Non-adherence is defined as reporting any non-adherence on the MARS (total score \<25). Adherence is defined as a score of 25."

National Institute on Minority Health and Health Disparities (NIMHD)

NYU Langone Health

Anti-Infective Agents

All Drugs and Chemicals

Carbamide Peroxide

H. pylori diagnostic test: C13 urea breath test

H. pylori diagnostic test: H. pylori stool antigen test

HPSA

H. pylori diagnostic tests: H. pylori serology test, C13 urea breath test

UBT and HPSA

H. pylori diagnostic test: H. pylori serology test

Serology (two stage)

Jyh-Ming Liou, MD,PhD

There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies. A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of diagnostic tests in a population-based H. pylori screening and gastric cancer prevention program. The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to four groups with different combination tests.

Background: There are still some unsolved questions regarding population-based screening program for H. pylori infection to prevent gastric cancer, such as how to perform the optimal screening strategies.

Objective: A prospective, randomized trial will be conducted to compare the acceptability, compliance (/adherence), and accuracy of C13 UBT and HpSA in a population-based H. pylori screening and gastric cancer prevention program.

Methods：Open labeled, randomized controlled trial The investigators will recruit 10,000 adults with age of ≥20 years who have not received H. pylori screening or treatment. Eligible patients will be randomly 1:1:1:1 allocated to (A) The carbon-13 urea breath test (C13 UBT), (B) H. pylori stool antigen test (Vstrip® HpSA), (C) Both C13 UBT and HpSA, (D) Two-stage screening method (serology screening only, and then C13 UBT for confirmation if serology test is positive).

Outcome analysis:

1. Detection rate of H. pylori infection
2. To compare the compliance(/adherence) of screening tests for H. pylori infection in the two randomized groups.
3. To assess the diagnostic accuracy of these tests.
4. To verify the compliance(/adherence) and feasibility of this two-stage screening method
5. Long-term Outcomes: To assess the risk reduction of gastric cancer

Screening Strategy for Gastric Cancer Prevention

Identification of the Optimal Screening Strategy for Gastric Cancer Prevention

The positivity rate of H. pylori infection between different study arms, respectively in ITT and PP analysis.

Completion rates of the study (from enrollment to the diagnosis of H. pylori; from enrollment to the treatment of H. pylori infection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)	NCT03597672	Neoplasm, Stoma... H. Pylori Infec... Chronic Atrophi...		20 Years - 70 Years	West China Hospital
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection	NCT02090062	Early Gastric C...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine
Patient-Centered Cancer Prevention In Chinese Americans	NCT03340454	H. Pylori Infec...	Test-and-treat ... Usual care of E...	21 Years -	NYU Langone Health
Screening Strategy for Gastric Cancer Prevention	NCT05387005	H. Pylori Infec...	UBT HPSA UBT and HPSA Serology (two s...	20 Years -	National Taiwan University Hospital
Early Detection and Screening Strategy of Gatric Cancer in Sichuan Province-A Prospective Cohort Study (WCH-GC-SIGES-01)	NCT03597672	Neoplasm, Stoma... H. Pylori Infec... Chronic Atrophi...		20 Years - 70 Years	West China Hospital
Difference in H. Pylori Infection Rate of EGC Patients Before and After Endoscopic Resection	NCT02090062	Early Gastric C...		18 Years - 90 Years	Shanghai Jiao Tong University School of Medicine

Spots Global Cancer Trial Database for h. pylori infection