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A Study of Pre-Malignant Gastric Conditions

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ClinicalTrials.gov Identifier: NCT05021029
Recruitment Status : Enrolling by invitation
First Posted : August 25, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
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.

Condition or disease
Intestinal Metaplasia Chronic Gastritis Atrophic Gastritis Autoimmune Gastritis Intestinal Dysplasia

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: A Study of Pre-Malignant Gastric Conditions
Actual Study Start Date : July 13, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : April 12, 2024



Primary Outcome Measures :
  1. Pre-malignant progression [ Time Frame: 2024 ]
    Review the number of patients with gastric conditions and any progression to advanced pre-neoplasia/malignancy or cancer.


Secondary Outcome Measures :
  1. Recruitment response rates [ Time Frame: 2024 ]
    Review number of patients response rates who donated full/partial biospecimen samples.


Biospecimen Retention:   Samples With DNA
With patient consents, study team will collect saliva, stool, blood and/or gastric biopsy or gastric juices.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from University of California Davis Health patients of all races and ethnicities.
Criteria

Inclusion Criteria:

  • 18 years and over
  • who have been diagnosed or suspected of having pre-malignant gastric conditions: chronic gastritis, atrophic gastritis, intestinal metaplasia or intestinal dysplasia
  • diagnosed with premalignant conditions during the last 5 year (2015-2020)
  • or recently diagnosed eligible patients who have been diagnosed or suspected of having pre-malignant gastric conditions and are scheduled for endoscopy.

Exclusion Criteria:

  • We will not include children (anyone under the age of 18), individuals unable to consent, pregnant women, or prisoners.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021029


Locations
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United States, California
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Luis G Carvajal-Carmona, PhD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT05021029    
Other Study ID Numbers: 1614453
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precancerous Conditions
Gastritis
Gastritis, Atrophic
Metaplasia
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Neoplasms