Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Adenocarcinoma

Gastroesophageal Reflux

Barrett Esophagus

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Esophageal Motility Disorders

Esophageal Spasm, Diffuse

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Precancerous Conditions

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

400 eligible primary care providers (PCPs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible PCPs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for providers to complete a paper survey at PCP clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.

100 eligible gastroenterologists (GIs) will be recruited across the 7 participating sites to complete an anonymous survey. The survey will be distributed to eligible GIs by the study site research coordinator via anonymous REDCap internet survey with 2 additional automated electronic reminders. There will also be opportunities for GIs to complete a paper survey at provider clinic meetings which will be collected by only the site research coordinator to maintain response anonymity.

500 eligible patients will be recruited across the 7 participating sites to complete a survey. The survey will be distributed to eligible patients at the time of a clinic appointment, via telephone, or via a REDCap internet survey that will allow for 2 additional electronic phone call reminders and 1 email reminder.

To assess PCP demographics, attitudes, and perceived barriers to BE screening, we have developed a PCP survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess PCP knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 PCPs.

Primary Care Provider Survey

To assess GI demographics, attitudes, and perceived barriers to BE screening, we have developed a GI survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess GI knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 GIs.

Gastroenterologist Survey

To assess patient knowledge, attitudes, and barriers to completion of BE screening, we will use a theoretical model of patient behavior on the Health Behavior Framework to guide selection of relevant variables for survey development including 4 domains: knowledge about BE and EAC, potential barriers to BE screening completion, patient attitudes and demographic information. Prior to distribution, the survey will be refined and pretested among a sample of 10 patients with each participant completing a cognitive interview prior to distribution.

Patient Survey

Sachin Wani, MD

The goal of this study is to optimize Barrett's Esophagus (BE) screening to reduce the incidence, morbidity, and mortality of Esophageal Adenocarcinoma (EAC).

The initial step to achieve this goal is to study shortcomings of the current BE screening referral processes in the United States. These shortcomings will be identified through completion of two synergistic aims that assess:, (1) provider knowledge, attitudes, and barriers to BE screening referral and (2) patient knowledge, attitudes, and barriers to completion of BE screening. The central hypothesis is that there are patient- and provider-level factors that can be modified to improve BE screening adherence. This hypothesis was formulated based on strong preliminary data demonstrating significant single-mindedness among gastroenterologists regarding BE screening criteria.

Survey Study on Barrett's Esophagus Screening

Study of Compliance, Practice Patterns, and Barriers REgarding Established National Screening Programs for Barrett's Esophagus: SCREEN-BE

This investigator will conduct a survey study among primary care providers and gastroenterologists at 7 large health systems in the U.S.-including 4 tertiary care referral centers and 3 safety-net health systems. Based on constructs from Social Cognitive Theory and Theory of Reasoned Action, the survey will assess provider knowledge, attitudes, and barriers to BE screening among at-risk individuals.

This investigator will conduct a survey study among patients at 7 large health systems in the U.S. Based on constructs from the Health Behavior Framework, the survey will assess patient knowledge, attitudes, and barriers to BE screening. To accomplish these study aims, this investigator has assembled a strong and diverse team with complementary areas of expertise in Barrett's esophagus, and survey research.

American College of Gastroenterology

University of Colorado, Denver

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Esophageal Cancer

Coagulants

Lugol's solution

UPPER ENDOSCOPY

Narrow-Band Imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect oesophageal squamous cell carcinoma (SCC) and appears more specific than Lugol chromoendoscopy in expert centres but its specificity in current practice is not known. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy to detect oesophageal SCC and high-grade dysplasia (HGD) in current practice (including tertiary care centres, local hospitals and private clinics).

Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population

Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population: a Randomised Controlled Multicentre Trial

Hôpital Edouard Herriot

Professor

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Anemia, Iron-Deficiency

Iron Deficiencies

Anemia

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Hematologic Diseases

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Micronutrients

Iron

In case of a positive immunochemical fecal occult blood test result, colonoscopy will be the first examination

In case of a negative immunochemical fecal occult blood test result, upper endoscopy will be the first examination

Participants will be provided with a single immunochemical fecal occult blood test. Participants will introduce a small sample of feces inside and bring the test to the hospital

Immunochemical fecal occult blood test

A colonoscopy (procedure performed using a scope design to examine the large bowel) will be offered to the participants

Colonoscopy

An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants

Upper endoscopy

Marta Carrillo, MD, PhD

ENRIQUE QUINTERO, MD. PhD.

Antonio Z Gimeno García, MD PhD

Zaida Adrián de Ganzo, MD PhD

David N Pérez, MD PhD

Marta Carrillo Palau, MD PhD

Enrique Quintero, MD, PhD

Prospective study to test whether the immunochemical fecal occult blood test (FIT) for colorectal cancer (CRC) helps to prioritize patients with iron deficiency anemia for colonoscopy.

This is a multicenter (two centers), prospective study to test the accuracy of FIT for CRC detection in patients with severe IDA and its potential value for prioritizing colonoscopy.

An appointment with a gastroenterologist will be scheduled for patients with IDA referred for upper gastrointestinal endoscopy or colonoscopy. The gastroenterologist will check the inclusion and exclusion criteria. Eligible patients will sign the informed consent to carry out the following procedures:

1. Blood analysis to rule out celiac disease (anti-transglutaminase IgA antibodies and IgA).
2. A quantitative fecal immunological test (FIT: OC-Sensor ®) will be provided.
3. An appointment for colonoscopy and gastroscopy will be provided after completion of the FIT in all patients. During gastroscopy, duodenal biopsies from the second portion of the duodenum and duodenal bulb will be taken to rule out celiac disease. Biopsies from the stomach will be also taken to assess helicobacter pylori infection.
4. In patients with severe anemia colonoscopy and upper endoscopy will be prioritized (\<20 days) (primary outcome).
5. Patients with colonoscopy and gastroscopy without significant lesions, will be scheduled for the performance of a capsule endoscopy.
6. Endoscopists will be blind for the FIT results.
7. the following information will be collected: consumption of acetylsalicylic acid, non steroidal anti inflammatory drugs, oral anticoagulants, corticosteroids and proton pump inhibitors (PPI). In the case of patients receiving treatment with PPIs, they will be removed 15 days before the completion of the FIT and not resumed until the performance of the upper endoscopy.

The hypothesis of the study is that one-time FIT is a useful tool for increasing the efficiency of colonoscopy and can be used to prioritize outpatient colonoscopy in patients with IDA. In order to calculate the sample size required for the study, the investigators have assumed that FIT is positive in 25% of cases with iron deficiency anemia and 20% of them would have an advanced colorectal neoplasia at colonoscopy whereas only 10% of advanced colorectal neoplasias would be found in the remaining 75% patients with a negative FIT. Considering a type I error (alpha) of 5%, a power of 80% and a percentage of losses of 15%, 550 patients will be necessary to include. The investigators estimate that approximately 15% of these patients (n=83) will have severe anemia.

Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)

Usefulness of Fecal Immunochemical Test in the Diagnosis Algorithm of Iron Deficiency Anemia.

In order to calculate the positive predictive value, the number of patients with events (colorectal cancers) will be divided among the number of positive immunochemical fecal tests

In order to calculate the positive predictive value, the number of patients with a significant lesion (i.e. colorectal cancer, advanced adenoma, inflammatory bowel disease, angiodysplasia, gastric cancer, watermelon stomach, gastric/duodenal ulcer, ampulloma, erosive gastritis/duodenitis) will be divided among the number of positive immunochemical fecal tests.

In order to calculate the negative predictive value, the number of patients without a significant lesion will be divided among patients with a negative immunochemical fecal test

Hospital Universitario de Canarias

Hypoglycemic Agents

Bone Density Conservation Agents

Gastrointestinal Agents

Vitamins

Metformin

Vitamin D

Cholecalciferol

Omeprazole

Proton Pump Inhibitors

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Barrett's esophagus patients who have no dysplasia or low grade dysplasia

Barrett's esophagus with high grade dysplasia

28-day run-in phase during which subjects are treated with a proton pump inhibitor (omeprazole 20 mg po q day or an equivalent dose of another proton pump inhibitor).

These patients (indefinite for dysplasia, LGD, or no dysplasia) will take vitamin D3 50,000 IU once a week for 12 weeks following the upper endoscopy.

Due to the risk of progression, subjects with Barrett's esophagus with high grade dysplasia will take vitamin D3 50,000 IU once a week for 2 weeks.

After the run-in phase subjects will undergo an upper endoscopy for Barrett's surveillance or Barrett's mapping as part of routine clinical care. At the time of endoscopy, in addition to large cup forceps biopsies obtained for surveillance or mapping as part of standard care, research biopsies will be obtained for the study. Following vitamin D3 supplementation, all subjects will undergo a repeat upper endoscopy for additional large cup forceps biopsies for measurement of post-treatment mucosal levels.

upper endoscopy

500mg for the first week, 1000mg during the second week, 1500mg during the third week, maximum dose of 2000mg in the fourth week

Linda Cummings, MD

This study is being conducted to determine if vitamin D supplementation increases the level of a protein that may be involved in decreasing the risk of esophageal cancer in patients with Barrett's esophagus. Subjects with Barrett's esophagus will take vitamin D supplementation for 2-12 weeks depending on the severity of their condition, and receive an upper endoscopy procedure before and after vitamin D supplementation trial.

28-day run-in phase during which subjects are treated with a proton pump inhibitor (omeprazole 20 mg po q day or an equivalent dose of another proton pump inhibitor). The purpose of the run-in phase is to minimize esophagitis, which can cause histologic changes that can be confused with dysplasia. After the run-in phase, subjects will undergo an upper endoscopy for Barrett's surveillance or Barrett's mapping as part of routine clinical care. At the time of endoscopy, research biopsies will be obtained for the study. Subjects eligible and continuing in the study will take vitamin D3 (Cholecalciferol) 50,000 IU capsules once weekly with or without daily metformin for a total of two or twelve weeks depending on the severity of Barrett's esophagus. After completion of vitamin D3 subjects will return for an EGD (endoscopy) and biopsies for the research study.

Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus

Effect of Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus

To determine whether vitamin D supplementation induces 15-Prostaglandin dehydrogenase expression as measured by RT-PCR in Barrett's esophagus

To determine whether vitamin D supplementation leads to decreased prostaglandin E2 expression in Barrett's esophagus

To determine whether vitamin D supplementation affects cyclooxygenase-2 expression in Barrett's esophagus

To determine whether 15-Prostaglandin dehydrogenase expression in Barrett's esophagus differs between RT-PCR and immunohistochemistry

To determine whether vitamin D supplementation affects levels of Ki-67, a marker for proliferation, in Barrett's esophagus

To determine whether vitamin D supplementation affects levels of caspase, a marker for apoptosis, in Barrett's esophagus

To determine whether vitamin D supplementation affects insulin resistance in Barrett's esophagus

Case Comprehensive Cancer Center

Infections

Symptoms and General Pathology

Communicable Diseases

Disease Attributes

Non-cancer patients scheduled for upper endoscopy

Upper endoscopy would be performed. Biopsy would be taken from oesophageal cancer tissue and adjacent non-cancerous mucosa

Upper endoscopy would be performed. Random biopsy would be taken from normal non-cancer esophageal mucosa.

Hon Chi Yip, FRCSEd

Philip Wai Yan Chiu, MD

Hon Chi Yip, FRCSEd (Gen)

This is a prospective study on the microbiota associated with oesophageal squamous cell carcinoma (SCC). Patients with newly diagnosed SCC of oesophagus would be recruited for taking samples of oral and oesophageal rinse, tissue biopsies for investigation of the microbiota of oesophageal cancer. Control patients would be identified from patients scheduled for routine endoscopy.

Oesophageal carcinoma significantly contributes to the global cancer burden ranking as the sixth leading cause of global cancer-related death. Oesophageal squamous cell carcinoma (OESCC) is one of the most common type of upper gastrointestinal (UGI) carcinoma in some regions globally, particularly China and Japan in Asia. The disease has an extremely poor prognosis, with overall 5-year survival rates of less than 30%, mainly due to late stage at diagnosis and high likelihood of distant metastases. Although OESCC is associated with risk factors including smoking and alcohol, the aetiology of OESCC is still poorly understood.

Increasing evidence indicates a key role for bacterial microbiota in carcinogenesis. Emerging data implicates the human microbiome in a variety of cancers, most notably Fusobacterium in colorectal cancer and Helicobacter in gastric cancer. The consortium of bacterial microbiome colonizing the gastrointestinal tract is extensive and interact in a complex manner. The microbiome may interact with genetic and environmental factors to metabolize dietary constituents and xenobiotics, among other functions. When the microbial balance is disturbed, the microbiota could alter host cell proliferation and death, manipulate the immune system, and influence host metabolism, giving rise to carcinoma. Several studies have reported an important role of the human microbiota in upper gastrointestinal carcinoma and found associations between the microbiota and some diseases of the UGI tract, such as esophagitis and Barrett esophagus, and with squamous dysplasia and squamous carcinoma of the oesophagus. Another even less well known is the role of the fungal microbiome in OESCC.

Here the investigators will seek to evaluate the role of the bacterial and fungal microbiome in OESCC and the host microbe interactions that may play a role in the understanding and management of OESCC.

Study questions:

1. Does the microbiome differ between OESCC and normal patients?
2. Does the microbiome change from normal through premalignancy to malignancy?
3. What are the mechanisms involved in the microbiome and the development or progression of OESCC?

Study design:

This is a prospective study. The study will be carried out in accordance with the Declaration of Helsinki.

Patients would be recruited from the Prince of Wales Hospital from Jun 2020 to May 2025. 100 patients with newly diagnosed OESCC or oesophageal squamous dysplasia will be recruited to the test group. 100 patients undergoing an oesophagogastroduodenoscopy (OGD) without a history of malignancy will be recruited to the control group. The expected duration of subject participation is less than two months.

The study has two visits, as follows:

1. Visit 1:

   i. To discuss about the project and to sign the informed consent form; ii. To collect oral rinse 20ml; iii. To complete questionnaire: Gut Microbe - Medical and health questionnaire.
2. Visit 2:

To have OGD. Visit 2 will be performed within two months post Visit 1 and must before treatment.

i. Test group: With examination of the lesion with biopsy of tumor, biopsy of adjacent normal tissue, flush with normal saline.

ii. Control group: Will have a biopsy of normal tissue and flush with normal saline.

Sample size justification:

This is a prospective study with no previous data based on OESCC. But based on data from head and neck squamous cell carcinoma (HNSCC) with some overlap in traditional risk factors the investigators target to recruit at least 100 OESCC patients and 100 healthy subjects. In HNSCC study using 54 HNSCC tumour tissues and the adjacent normal tissues has generated 16S rRNA short reads able to discriminate cases from controls. A total of 77 bacterial genera with \>0.1% mean relative abundance was observed in tumour tissues. A rarefaction analysis indicated that at least 73 genera can be detected from any of 35 samples, suggesting that recruitment of 100 patients and 100 controls meets the minimized sample size to contain nearly full spectrum of oral bacteria and is expected to have a power of 0.8 and confidence level of 95% to characterize oral microbiota dysbiosis between cases and controls.

Independent variables

The following independent variables will be examined to evaluate the association of the methylation panel and OESCC:

1. Clinical factors: TNM staging of disease, comorbidities;
2. Cancer risk factors: smoking history, alcohol consumption;
3. Patient factors: sex, age;
4. Histologic characteristics: tumour depth, extracapsular spread, lymphovascular invasion, perineural invasion.

Samples:

Oral rinse: Before the procedure, an oral rinse would be performed by asking all patients to rinse the oral cavity with 20ml normal saline. The resultant solution would be kept for subsequent analysis.

Endoscopic procedures Endoscopic procedures would be performed by doctors with expertise on performing upper endoscopy. It would be conducted at the Combined Endoscopy Center, Prince of Wales Hospital. Topical local anaesthetic will be applied to the oropharynx. Endoscopes with magnification /dual focus and NBI function would be used. A soft black hood would be attached to the tip of the endoscope for better focal length adjustment.

Patients in the test group would then undergo endoscopy with one biopsy of the tumor and one biopsy of the adjacent normal esophageal mucosa. In addition, oesophageal rinse would also be performed by flushing the esophagus gently with 20ml normal saline and the fluid suctioned and collected for analysis.

Patients in the control group would undergo endoscopy as per usual clinical practice. One biopsy would be taken from normal esophageal mucosa for analysis. Similarly, oesophageal rinse would be performed.

Experiments DNA extraction and bisulphite modification: DNA from microdissected fresh tissues and saliva will be extracted with phenol-chloroform, precipitated in 100% ethanol, centrifuged at 5100 rpm for 45 minutes, washed in 70% ethanol twice, dissolved in LoTE buffer (10mM TRIS hydrochloride, 1mM EDTA buffer, pH 8), and stored at -80°C.

RNA extraction: Fresh tissue will be stored in RNAlater for extraction of RNA and stored in -80°C.

Genomic analysis: Utilizing next generation sequencing analysis for copy number aberrations and single nucleotide variations to analyse the samples collected using shotgun massive parallel sequencing as previously described. We will also use sequencing to analyse the microbiota of the cohort. Bacterial 16S rRNA gene sequencing: An aliquot of DNA will be used to screen oral microbial community using 16S rRNA gene V3- V4 region amplicon sequencing 24. QIIME2 with the latest Silva ribosomal RNA database will be used to classify amplicon sequence variant, with operational taxonomic table showing the proportion of bacterial reads per sample. Mycobiota ITS gene sequencing: we will target mycobiota internal transcribed spacer gene (ITS) to characterize oral fungal community. A short region of ITS1 (\~270 bp) will be PCR amplified and sequenced using MiSeq. The reads will be processed against a fungal UNITE database, and the classification tables will be generated at the species-, genera- and OTU-level for statistical analyses.

Expression analysis: The investigators will determine if these genomically altered tumors express specific changes in signaling proteins using immunohistochemical staining (IHC) and protein profiling by protein arrays. FFPE-sections or frozen tissues will be harvested for alongside with genomic characterization study for IHC analyses, or protein profiling. For IHC analysis or protein profiling, a total of 5 FFPE-slides will be employed for IHC or protein extraction for protein profiling as previously published. RNA will be extracted and subjected to RNA analyses, including RNA-seq, expression array and RT-PCR analyses so as to determine specific gene expression patterns of oesophageal tumors, as well as expression of potential biomarkers.

Bacterial Culture: To further understand the role of the microbiome as a biomarker in OESCC tissue specimens will be cultured for bacteria identified in sequencing to be significantly enriched in tumours. Tissue specimens were aseptically macerated with disposable scalpels and vortexed for 30 seconds in PBS (500 l), and the neat suspensions were used to make 10-fold 2 ) dilutions. Neat suspensions (50 l) were each spread onto blood agar (BA), fastidious anaerobe agar (FAA) (BA and FAA supplemented with 5% defibrinated sheep blood; TCS Biosciences Ltd.), and Sabouraud's agar (Lab MTM; International Diagnostics Group plc). The dilutions and final PBS washes of the specimens (see above) were spread onto BA and FAA. BA and Sabouraud's agar plates were incubated aerobically at 37°C for 48 h. FAA plates were incubated in an anaerobic cabinet at 36°C for 96 h.

Outcomes measures

1. Loco-regional recurrence free survival will be recorded from time of diagnosis to time of recurrence locally, regionally or local and regionally.
2. Disease specific survival will be recorded from time of diagnosis to time of death from OESCC.
3. Overall survival will be recorded from time of diagnosis to time of death from all causes.

Statistical Analysis Association between microbes, surgery treatment, and individuals' metadata (e.g., gender, age, smoking, drinking, T/N stages, survival, recurrence) will be analysed using a mix of ordination, non-parametric multivariate analysis of variance, matrix correlation, chi-square test, generalized linear model, or conditional logistic regression models. The performance of the final biomarkers will be assessed by cross-validation and summarized by c-index score to assess the concordance between model and comparison groups using ROC curves. All multiple testing corrections will be performed by computing FDRs using the BenjaminiHochenberg method, and adjusted p values \< 0.05 will be considered statistically significant.

1. Oral and esophageal rinse
2. Biopsy samples from oesophageal cancer, adjacent non-cancer mucosa, as well as random oesophageal biopsies from healthy individuals

The Microbiome of Oesophageal Squamous Cell Carcinoma

Pattern of culture from specimens obtained, compared between cancer and non-cancer

Time of diagnosis to time of recurrence locally, regionally or local and regionally.

Time of diagnosis to time of death from OESCC.

Time of diagnosis to time of death (All cause)

Chinese University of Hong Kong

Associate Consultant

Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE.

Glenn M Eisen, MD, MPH

Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area.

Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color.

The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.

Study of Endoscopic Barrett's Esophagus Diagnosis

A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus

Oregon Health and Science University

Stomach Neoplasms

Atrophy

Gastritis, Atrophic

Gastritis

Stomach Diseases

Pathological Conditions, Anatomical

Gastroenteritis

Stomach Cancer

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)

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
Survey Study on Barrett's Esophagus Screening	NCT04408105	Gastroesophagea... Barrett's Esoph... Esophagus Adeno...	Primary Care Pr... Gastroenterolog... Patient Survey	18 Years - 99 Years	University of Colorado, Denver
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population	NCT04224896	FRENCH STUDY	UPPER ENDOSCOPY	18 Years - 80 Years	Hôpital Edouard Herriot
Narrow-Band Imaging (NBI) Versus Lugol Chromoendoscopy in the Detection of Oesophagus Squamous Cell Carcinoma in High Risk Population	NCT04224896	FRENCH STUDY	UPPER ENDOSCOPY	18 Years - 80 Years	Hôpital Edouard Herriot
Usefulness of Fecal Immunochemical Test in Iron Deficiency Anemia (IDAFIT)	NCT02792023	Colorectal Canc...	Immunochemical ... Colonoscopy Upper endoscopy	18 Years -	Hospital Universitario de Canarias
Vitamin D Supplementation on 15-Prostaglandin Dehydrogenase Expression in Barrett's Esophagus	NCT01465113	Short Segment B... Long Segment Ba...	Omeprazole Vitamin D3 Vitamin D3 upper endoscopy Metformin	18 Years -	Case Comprehensive Cancer Center
The Microbiome of Oesophageal Squamous Cell Carcinoma	NCT04425122	Esophageal Canc... Microbial Colon...	Upper endoscopy Upper endoscopy	18 Years -	Chinese University of Hong Kong
Study of Endoscopic Barrett's Esophagus Diagnosis	NCT00591461	Barrett's Esoph... GERD		18 Years - 80 Years	Oregon Health and Science University
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
Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks	NCT02464618	Compliance Colon Cancer	Social contact ...	18 Years -	Howard University

Spots Global Cancer Trial Database for upper endoscopy