Nanopore Sequencing for Pancreatic Cancer Detection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Perioperative antibiotics

Disqualifiers: Pregnancy, Institutionalized, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

8 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial evaluates whether testing of bile with nanopore sequencing results in earlier detection of bacteriobilia (bacteria in bile) that may lead to surgical site infections in patients undergoing surgery for benign or malignant pancreatic tumors. Surgical site infections are a significant source of poor outcomes in patients undergoing surgery for pancreatic tumors. In most patients who develop this kind of infection, the bacteria identified as causing the infection is also frequently found to be in the bile at time of surgery. Usage of nanopore sequencing for detection of bacteria in the bile of patients undergoing surgery may allow doctors to prevent surgical site infections or treat them sooner or more effectively.

Research Team

Marina R. Walther-Antonio, PhD

Principal Investigator

Mayo Clinic in Rochester

Mark J. Truty, MD, MS

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for surgery on my pancreas with consent.

Exclusion Criteria

I am currently pregnant.

Patients who are institutionalized or incarcerated

I am unable to understand and make decisions about my treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Sample Collection

Patients undergo standard of care surgery with bile sample collection for routine laboratory testing or nanopore sequencing

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for surgical site infections and antibiotic stewardship

4 weeks

1 visit (in-person) at 2 weeks, 1 visit (in-person) at 4 weeks

Follow-up

Participants' medical records are reviewed for surgical site infections and antibiotic use

Up to 90 days

Treatment Details

Interventions

• Oxford Nanopore Sequencing

Trial Overview 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.

Participant Groups

Group I: Arm II (biospecimen, nanopore sequencing, routine testing) Experimental Treatment 3 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 Control 2 Interventions

Patients undergo the collection of bile samples during standard of care surgery. Samples undergo routine laboratory testing.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+