Study To Evaluate Microbiome Composition And Diversity Signature Using Endoscopic Ultrasound
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-000269
Sponsor Protocol Number: 21-000269
About this study
The specific aims of this study are as follows:
Aim # 1: To determine the prevalence of pancreas solid tumor intratumoral microbiota, their composition and diversity in specimens prospectively acquired via endoscopic ultrasound (EUS).
Aim # 2: To investigate both the oral and duodenal microbiome of such patients to evaluate for similarities and differences.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Target accrual: Approach 100 patients with a clincially indicated endoscopic ultrasound procedure with ideally at least 70 subjects agreeing to consent at the Mayo Clinic Rochester location.
Subject population (children, adults, groups): Patients (>18 years of age) with a solid pancreas tumor requiring a clinical endoscopic ultrasound for diagnostic and staging purposes will be approached and enrolled. The study objective is to complete all aspects of the study for 70 patients, and therefore will require approaching approximately100 patients for this proof of principle study. The corresponding Mayo Clinic electronic medical record for up to 5 years following enrollment is needed for complete evaluation.
Describe subject eligibility criteria, including the population(s) from which biospecimens/information will be obtained: All patients with a clinically indicated endoscopic ultrasound procedure with an indication for a solid pancreas tumor evaluation for diagnosis and staging, who are over 18 years of age, not pregnant and freely of their own will, able to complete a written informed consent.
Describe provisions for inclusion of minorities: As per above all individuals are eligible. This study will not target a particular population or demographic or ethnicity.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Ferga Gleeson, M.B., B.Ch. |
Closed for enrollment |
Contact information:
Ferga Gleeson
5075381361
Contact Usgleeson.ferga@mayo.edu
|
More information
Publications
Publications are currently not available