Health TrialsbyHealthPanel

Molecular Detection of Advanced Neoplasia in Pancreatic Cysts

ConditionPancreas Cyst
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorMayo Clinic

About this trial

Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris

Patients with suspected cystic neoplasm of the pancreas

Able to provide written informed consent

Disqualifiers

Pregnant and/or nursing

Incarceration

Imaging showing possible pancreatic cancer

Prior history of pancreatic cancer or pancreatic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Blood, stool, pancreatic juice and cyst fluid collection

    Diagnostic test

    Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.

  • Pancreatic Surgery

    Procedure/Surgery

    Surgical resection of pancreatic cyst

  • Endoscopy Exam

    Procedure/Surgery

    Clinically indicated endoscopic ultrasound

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Clinical Follow-upExperimental treatment 2 interventions
Group B: SurgicalOther 2 interventions

Trial outcomes

Primary outcomes

1

Biospecimen Acquisition

Number of biospecimens collected

Time frame
5 years
2

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

To validate the diagnostic accuracy of cyst fluid methylated DNA marker (MDM) assays for detection of HGD and cancer in pancreatic cysts undergoing surgical resection

Time frame
5 years

Secondary outcomes

1

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

To evaluate the performance of cyst fluid MDM assays for predicting development of HGD or cancer during 3-year follow-up in study patients who are initially managed non-operatively

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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