Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05021029 |
| Other study ID # |
1614453 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2021 |
| Est. completion date |
October 31, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
University of California, Davis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
