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Molecular Detection for Pancreatic Cysts

N/A

Recruiting

Led By Shounak Majumder, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with suspected cystic neoplasm of the pancreas

Be older than 18 years old

Must not have

History of receiving systemic chemotherapy or abdominal radiation within the last 5 years

Prior history of pancreatic cancer or pancreatic surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing blood, stool, pancreas cyst fluid, and pancreas juice to find new ways to diagnose dangerous changes in pancreatic cysts. It focuses on patients with high-risk pancreatic cysts. Researchers hope to identify markers in these samples that can help doctors determine if a cyst is likely to become cancerous.

Who is the study for?

This trial is for patients with suspected pancreatic cysts who can consent to the study. They must meet specific criteria indicating a higher risk of cancer in their cysts. People are excluded if they've had previous treatments for pancreatic lesions, recent cancer other than skin cancer, past pancreas surgery or necrosis, current pregnancy or nursing, or chemotherapy/radiation within 5 years.

What is being tested?

The study is testing new diagnostic methods using blood, stool, pancreatic juice and cyst fluid to detect malignant or pre-malignant changes in pancreatic cysts. It involves collecting samples from participants and may include an endoscopy exam and possibly surgery.

What are the potential side effects?

Potential side effects could arise from sample collection procedures like discomfort or bleeding at the draw site for blood tests; pain, infection risks from endoscopy exams; and typical surgical risks such as infection or complications post-operation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I might have a cystic tumor in my pancreas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had chemotherapy or radiation to my abdomen in the past 5 years.

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I have had pancreatic cancer or surgery on my pancreas before.

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I have had treatment for a pancreatic cyst before.

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I was diagnosed with cancer, other than non-melanoma skin cancer, in the last 5 years.

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My scans may show signs of pancreatic cancer.

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I have had pancreatic necrosis in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Biospecimen Acquisition

High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group

Secondary study objectives

High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group

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

Group I: SurgicalExperimental Treatment2 Interventions

Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.

Group II: Clinical Follow-upExperimental Treatment2 Interventions

Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pancreatic Surgery

2007

Completed Phase 2

~660

0 / 7Eligibility criteria met