Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Rare Diseases

Communicable Diseases

Stomach Neoplasms

Atrophy

Gastritis, Atrophic

Gastritis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Chronic Graft Versus Host Disease

Stomach Cancer

This happens on Day 0. Screening for EGD, biopsy samples from esophagus, stomach, gastrointestinal junction, and duodenum AE's.

After colonoscopy, the patient will undergo the EGD at which time biopsy specimens will be obtained.

Participants will also be provided with a home stool collection kit which they can bring to the endoscopy visit or mail back. Satisfaction questions will be administered 3-7 days after EGD-SC

esophagogastroduodenoscopy (EGD)

Haejin In, MD

Screening esophagogastroduodenoscopy (EGD )provides three distinct opportunities to decrease gastric cancer (GC) morbidity and mortality. has potential to discover cancer in early stages before the onset of symptoms, leading to higher rates of survival. Second, premalignant lesions such as adenomatous polyps, intestinal metaplasia and dysplasia can be discovered and removed with local resection, akin to polypectomies during screening colonoscopies, preventing the development of cancer. Third, EGD discovery and treatment of active Helicobacter pylori (HP) infection of the stomach provides an opportunity for primary prevention of GC.

The primary objective of the study is to evaluate the acceptability and feasibility of EGD-SC.

The secondary objectives are:

1. Estimate Median added time needed for EGD at the time of routine screening colonoscopy
2. Estimate the frequencies of adverse events
3. Estimate the percentage of pre-cancer and cancerous lesions including H. pylori infection, chronic atrophic gastritis, IM, dysplasia and GC among this high GC risk population
4. Investigate whether high-risk racial/ethnicity groups have different likelihood of uptake of EGD, and whether the likelihood is associated with patient beliefs, attitudes and knowledge of GC, perceptions of risk, motivators and barriers, and sociocultural factors, as well as patient preference and satisfaction with EGD-SC

A single-center, open label pilot study that will evaluate the acceptability and feasibility of EGD at time of routine screening colonoscopy (EGD-SC). The Pre-Study Screening is day -30 to day 0; EDG at time of routine screening colonoscopy and follow-up day five to seven.

Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy

Primary Objective: The Primary Objective of the Study is to Evaluate the Acceptability and Feasibility of EGD-SC

Linear Scale eligible for the study. The Wilcoxon signed-rank test will be used to assess the participants responses to EGD.

To achieve the goal of assessing feasibility of EDG-SC as well as estimates of effect size needed to determine sample size and power for the planned study, the investigator will collect data on the number of participants contacted, number eligible, and number who agree to EGD-SC.

Adverse events (AEs) will be evaluated and graded using the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 5.0

Rutgers, The State University of New Jersey

Surgical Oncology Associate Professor of Surgery

Pathological Conditions, Anatomical

Gastroenteritis

Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management

Patients with histologically confirmed gastric cancer (adenocarcinoma)

Patients without gastric malignant disease according to data obtained in upper endoscopy

Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer

Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)

Breath sampling will be performed by using a special sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Pepsinogen testing will be used in a subgroup to identify serological increased risk for atrophy

Breath sampling for VOC detection

Only for gastric cancer patients undergoing surgery (Group 1)

Surgery material collection for VOC headspace analysis

Routine endoscopic evaluation with a standard biopsy work-up according to updated Sydney system. Additional gastric contents for GC-MS and microbiota analysis in a subgroup. Endoscopy will be used only according to the clinical indications (in Group 4 - according to the results of pepsinogen tests)

Upper endoscopy

Faecal and gastric contents and biopsy samples for microbiota testing

Microbiota testing

Marcis Leja, MD, PhD

Daiga Santare, MD, PhD

Emmanuel Dias Neto, MD, PhD

Robinson Gonzalez, MD, PhD

Alejandro Corvalan, MD, PhD

Raul Murillo, MD, PhD

Andrii Lukashenko, MD, PhD

Hossam Haick, PhD

The study is aimed to determine the potential of volatile marker testing for gastric cancer screening.

The study will be addressing the role of confounding factors, including lifestyle factors, diet, smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers.

Patients with established disease (gastric cancer, precancerous lesions) as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil). In addition, group of persons from general population at average risk for developing the target disease and individuals being referred for upper endoscopy according to clinical indications will be also enrolled.

Testing of volatile markers will be conducted by one of two methods: 1) gas chromatography coupled to mass spectroscopy (GS-MS) and 2) sensor technology. Various sensors will be used and evaluated for the purpose.

The potential sources of volatile organic compounds (VOCs) in the breath will be addressed by studying VOC emission by using headspace analysis from cancer tissue, gastric contents, cancer cell cultures and H.pylori.

The potential role of gastric and faecal microbiota in the origin of VOCs in the breath will be addressed. Metabolome in the circulation will also get correlated to VOCs in the breath and with microbiome.

Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Biopsy samples from stomach for histological assessment and microbiota analysis Gastric content samples for GC-MS and microbiota analysis Faecal samples for occult blood testing and microbiota analysis

Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach

The role of confounding factors will be addressed to address their role in VOC emission

The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected

Identification of specific chemistries (GC-MS analysis) originating from gastric cancer

Comparative analysis between the performance of different sensor performance in target disease identification

Analysis of the role of gastric and faecal microbiota in the origin of VOCs in the exhaled breath

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy	NCT05566899	Gastric Cancer	esophagogastrod...	40 Years - 80 Years	Rutgers, The State University of New Jersey
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach	NCT04022109	Gastric Cancer Atrophic Gastri... Gastric Dysplas... H.Pylori Infect...	Breath sampling... Surgery materia... Upper endoscopy Microbiota test...	18 Years -	University of Latvia
Pilot Study of Stomach Cancer Early Detection and Prevention With Endoscopy	NCT05566899	Gastric Cancer	esophagogastrod...	40 Years - 80 Years	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for h.pylori infection