Study To Evaluate Microbiome Composition And Diversity Signature Using Endoscopic Ultrasound

Overview

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

gleeson.ferga@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20511049

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