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Nanopore Sequencing for Pancreatic Cancer Detection

N/A
Waitlist Available
Led By Mark J. Truty, MD, MS
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>= 18 year (yr) male (M) or female (F)
Undergoing pancreaticoduodenectomy or total pancreatectomy for any benign or malignant indication with informed consent
Must not have
Women who are pregnant
Patients without the cognitive capacity to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if nanopore sequencing can help detect bacteria that leads to surgical site infections in patients with pancreatic tumors.

Who is the study for?
This trial is for adults over 18 who are having surgery (pancreaticoduodenectomy or total pancreatectomy) for any pancreatic tumor, benign or cancerous. It's not open to pregnant women, those in institutions like prisons, people unable to consent, patients needing emergency surgery, or anyone already in a similar antibiotic study.
What is being tested?
The trial is testing nanopore sequencing—a rapid lab method—to detect bacteria in bile during pancreatic tumor surgeries. The goal is to see if this can prevent or improve treatment of surgical site infections by identifying harmful bacteria quickly.
What are the potential side effects?
Since the interventions involve diagnostic procedures rather than medications, typical drug side effects aren't expected. However, there may be risks associated with collecting biospecimens and potential discomfort from the laboratory procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for surgery on my pancreas with consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently pregnant.
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I am unable to understand and make decisions about my treatment.
Select...
I am having an emergency surgery for my pancreas.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improved antibiotic stewardship
Reduction in surgical site infections
Secondary study objectives
Cost effectiveness (reduced total hospital costs)
Timeliness of sample analysis

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (biospecimen, nanopore sequencing, routine testing)Experimental Treatment3 Interventions
Patients undergo the collection of bile samples during standard of care surgery. Samples undergo nanopore sequencing and routine laboratory testing.
Group II: Arm I (biospecimen collection, routine testing)Active Control2 Interventions
Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,079 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,953 Total Patients Enrolled
Mark J. Truty, MD, MSPrincipal InvestigatorMayo Clinic in Rochester
Marina R. Walther-Antonio, PhDPrincipal InvestigatorMayo Clinic in Rochester
Nicholas D ChiaPrincipal InvestigatorMayo Clinic in Rochester

Media Library

Laboratory Procedure Clinical Trial Eligibility Overview. Trial Name: NCT05523154 — N/A
Pancreatic Cancer Research Study Groups: Arm I (biospecimen collection, routine testing), Arm II (biospecimen, nanopore sequencing, routine testing)
Pancreatic Cancer Clinical Trial 2023: Laboratory Procedure Highlights & Side Effects. Trial Name: NCT05523154 — N/A
Laboratory Procedure 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523154 — N/A
~1 spots leftby Apr 2025
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