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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing whether new tests can help diagnose pancreatic cancer earlier.
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.Check my eligibility
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.See study design
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 belowSelect...
I might have a cystic tumor in my pancreas.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biospecimen Acquisition
High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
Secondary outcome measures
High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group
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
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,211 Total Patients Enrolled
4 Trials studying Pancreatic Cysts
436 Patients Enrolled for Pancreatic Cysts
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,925,332 Total Patients Enrolled
1 Trials studying Pancreatic Cysts
1,250 Patients Enrolled for Pancreatic Cysts
Shounak Majumder, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had chemotherapy or radiation to my abdomen in the past 5 years.I have had pancreatic cancer or surgery on my pancreas before.I have had treatment for a pancreatic cyst before.You are currently pregnant or breastfeeding.I was diagnosed with cancer, other than non-melanoma skin cancer, in the last 5 years.My scans may show signs of pancreatic cancer.I might have a cystic tumor in my pancreas.I have had pancreatic necrosis in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Clinical Follow-up
- Group 2: Surgical
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for volunteer participants in this trial?
"According to clinicaltrials.gov, this medical research is currently enrolling participants. Its inception dates back to the eleventh of May in 2018 and was most recently updated on December thirteenth 2021."
Answered by AI
How many individuals are presently partaking in this research endeavor?
"Yes, according to clinicaltrials.gov, this trial is currently enrolling participants and was first launched on May 11th 2018. It has since been updated on December 13th 2021 and requires 800 patients from one site to join the study."
Answered by AI
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