Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Rare Diseases

Atrophy

Gastrointestinal Diseases

Gastritis, Atrophic

Metaplasia

Precancerous Conditions

Gastritis

Gastroenteritis

Stomach Diseases

Chronic Graft Versus Host Disease

Luis G Carvajal-Carmona, PhD

To establish a prospective cohort of individuals diagnosed with gastric pre-malignant conditions (chronic gastritis, atrophic gastritis, autoimmune gastritis, intestinal metaplasia, intestinal dysplasia) to monitor and study disease progression. The Investigators will like to survey cohort participants for lifestyle behaviors and environmental exposures associated with gastric pre-malignancy and cancer. Analyzing patient biospecimens to identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies.

Initially, study coordinators will identify prevalent patients diagnosed with gastric pre-malignancy at UC Davis Health in the last five years or receive a list of eligible patients by a GI doctor at UC Davis Health. These individuals will be sent an invitation letter via mail or by physician, to participate in the study and will be provided with a reply slip authorizing contact by the research team. Individuals willing to participate in the study will be then contacted by research coordinators via phone/mail to:

i) Provide information about the study and answer questions (via phone call, video-conference, letter or email),

ii) Answer study questionnaire

iii) Sign study's informed consent to provide saliva, blood, urine and/or stool samples.

iv) Sign a HIPPA form to obtain permission to retrieve archival tumor blocks and pathology reports

Participants will be also asked for permission to regular re-contact and will be asked to inform study coordinators about future endoscopic appointments, where blood, stomach biopsies and stomach juice samples will be obtained. If the participant agrees, permission will be requested for these samples as well.

To recruit incident participants, the research coordinators will review endoscopic schedules and or be provided a list of patients who fit the criteria to identify participants suspected or diagnosed with gastric pre-malignant diseases. Participants will be asked to consent and asked to fill out a short version survey before their endoscopic procedure. Contact information will be collected (Phone, Address, Email) in order to send the full version of the survey later. Participants will be asked if they would like to donate a blood, saliva and urine sample and will be provided with a stool collection kit for home sampling, which will be returned to the research team in a pre-paid padded envelope. At the appointment, participants will also be asked if they would agree to provide tissue and/or gastric juices that will be obtained by their physician during their procedure or any leftover tissue after histological examination. For specimens requiring histological analyses, only once consents and/or HIPPA waivers are received will any leftover specimens be collected for this research study.

All participants (prevalent and incidence) will be contacted once a year to update surveys, clinical and risk factor information, consent and HIPPA waivers.

Data from the study questionnaire will be analyzed regularly using standard epidemiological methods. Biospecimens will be used for multiple omics approaches and results will be published regularly in medical and scientific journals and conferences.

With patient consents, study team will collect saliva, stool, blood and/or gastric biopsy or gastric juices.

A Study of Pre-Malignant Gastric Conditions

The UC Davis Cohort of Pre-Malignant and Malignant GastroIntestinal DisEases (TUMMIE) Study

Review the number of patients with gastric conditions and any progression to advanced pre-neoplasia/malignancy or cancer and identify and characterize host and microbiome biomarkers associated with initiation and progression of gastric pre-malignancies

Review number of patients response rates who donated full/partial biospecimen samples.

University of California, Davis

Colorectal Neoplasms

Barrett Esophagus

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Esophageal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Nestis® jet injector system with a bi-functional catheter

ESD (Endoscopic Sub-mucosal Dissection)is the first-intent method to treat superficial neoplasms of the digestive tract at it allows an en-bloc R0 resection. Following marking of the lesion margins, ESD comprises 3 steps: 1) liquid injection into the sub-mucosal space 2) circumferential (complete or partial) incision and 3) dissection of the submucosa. Several tools are necessary to perform ESD with the standard technique. Development of water jet with bi functional (injection and cutting) catheter allows time and significant reduction of perforation risk (due to multiple changes of instruments). For this purpose, Nestis introduced the Enki 2 pulsed jet technology with high pressure system to inject efficiently and at any time viscous solutions in direct viewing and retroflexion. Preliminary pig studies indicate that injection of glycerol, hyaluronate and hydroxyethlstarch with Enki 2 are possible. In addition, preclinical studies on living pig colon models using saline solutions have demonstrated that perforation rates and operating times are significantly reduced compared to a standard electrosurgical knife. The present clinical study is being performed to confirm this system capability to perform ESD in humans.

Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial

Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial.

Safety is measured in term of perforation rate and bleeding rate with immediate complication or delayed one after the procedure, at one month complications are not linked to the ESD procedure

Procedure is successful when the resection is complete with no residual tissue on the margins in depth and in the lateral part of the lesions.

no macroscopic nor microscopic local recurrence during follow up endoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Pre-Malignant Gastric Conditions	NCT05021029	Intestinal Meta... Chronic Gastrit... Atrophic Gastri... Autoimmune Gast... Intestinal Dysp...		18 Years -	University of California, Davis
Endoscopic Sub-mucosal Dissection With the Nestis® Jet Injector System With a Bi-functional Catheter: First Prospective Trial	NCT01913223	Barrett's Esoph... Intestinal Dysp... Esophageal Dysp... Colorectal Neop...	Nestis® jet inj...	18 Years -	Hospices Civils de Lyon
A Study of Pre-Malignant Gastric Conditions	NCT05021029	Intestinal Meta... Chronic Gastrit... Atrophic Gastri... Autoimmune Gast... Intestinal Dysp...		18 Years -	University of California, Davis

Spots Global Cancer Trial Database for intestinal dysplasia