Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
Recruiting · NCT04239573 · Observational (researchers observe without assigning treatment) · Lead sponsor: ECOG-ACRIN Cancer Research Group
View the official record on ClinicalTrials.gov →Interventions studied
Biopsy ProcedureBiospecimen CollectionComputed TomographyEndoscopic UltrasoundEndoscopic Ultrasound-Guided Fine-Needle AspirationMagnetic Resonance ImagingQuality-of-Life AssessmentQuestionnaire AdministrationSurgical Procedure
What this trial is about
The purpose of this study is to compare two approaches for monitoring pancreatic cysts as well as to identify associated biomarkers. The study doctors want to compare more frequent monitoring versus less frequent monitoring as well as identify biomarkers which may improve risk detection of transformation to pancreatic cancer. The study doctors want to learn which monitoring method and which biomarkers lead to better outcomes for patients.
Who can take part
Age range
50 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Patient must be ≥ 50 years and ≤ 75 years of age
- Patient must not have acute pancreatitis or a history of chronic pancreatitis
- Patient must have received a CT, MRI, or EUS within 6 months prior to enrollment that revealed one or more ≥ 1 cm pancreatic cyst(s).
- Patients of childbearing potential must not be known to be pregnant
- Patient must not have a prior diagnosis of pancreatic malignancy of any type
- Patient must not have a history of pancreatic resection
- Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible
- Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children)
- Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥ 10mm, cyst causing obstructive jaundice)
- Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection
- Patient must not be in any form of pancreatic cyst surveillance for \> 1 year, defined as organized, periodic up-to-date imaging directed towards the pancreatic cyst of interest
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must be ≥ 50 years and ≤ 75 years of age
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have acute pancreatitis or a history of chronic pancreatitis.
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must have received a CT, MRI, or EUS within 6 months prior to randomization that revealed one or more ≥ 1 cm pancreatic cyst (s).
- PRIOR TO ADDENDUM #5 08/13/2024: Patients of childbearing potential must not be known to be pregnant.
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a prior diagnosis of pancreatic malignancy of any type.
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a history of pancreatic resection.
- PRIOR TO ADDENDUM #5 08/13/2024: Patients with only pancreatic lesions without malignant risk (pancreatic pseudocyst or classic serous cystic lesion) are not eligible.
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a family history of pancreatic adenocarcinoma in one or more first-degree relatives (biological parents, full siblings or children).
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have pancreatic cyst morphology that would prompt immediate surgical consideration (enhancing mural nodule, solid component in cyst, pancreatic duct ≥10mm, cyst causing obstructive jaundice).
- PRIOR TO ADDENDUM #5 08/13/2024: Patient must not have a comorbid illness that precludes EUS or pancreatic cyst resection.
Where it is running
60 locations listed across 41 US states.
- University of Alabama at Birmingham Cancer Center - Birmingham, Alabama, United States
- University of South Alabama Mitchell Cancer Institute - Mobile, Alabama, United States
- Anchorage Associates in Radiation Medicine - Anchorage, Alaska, United States
- Anchorage Radiation Therapy Center - Anchorage, Alaska, United States
- Alaska Breast Care and Surgery LLC - Anchorage, Alaska, United States
- Alaska Oncology and Hematology LLC - Anchorage, Alaska, United States
- Alaska Women's Cancer Care - Anchorage, Alaska, United States
- Anchorage Oncology Centre - Anchorage, Alaska, United States
- Katmai Oncology Group - Anchorage, Alaska, United States
- Providence Alaska Medical Center - Anchorage, Alaska, United States
- Mayo Clinic Hospital in Arizona - Phoenix, Arizona, United States
- Mayo Clinic in Arizona - Scottsdale, Arizona, United States
- Baptist Health Medical Center - Little Rock - Little Rock, Arkansas, United States
- University of Arkansas for Medical Sciences - Little Rock, Arkansas, United States
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank, California, United States
- UC San Diego Health System - Encinitas - Encinitas, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Loma Linda University Medical Center - Loma Linda, California, United States
- Veterans Affairs Loma Linda Healthcare System - Loma Linda, California, United States
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles, California, United States
- University of California Davis Comprehensive Cancer Center - Sacramento, California, United States
- UC San Diego Medical Center - Hillcrest - San Diego, California, United States
- UCSF Medical Center-Mount Zion - San Francisco, California, United States
- UCSF Medical Center-Parnassus - San Francisco, California, United States
- UCSF Medical Center-Mission Bay - San Francisco, California, United States
- Smilow Cancer Hospital-Derby Care Center - Derby, Connecticut, United States
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield, Connecticut, United States
- Smilow Cancer Hospital Care Center at Glastonbury - Glastonbury, Connecticut, United States
- Smilow Cancer Hospital Care Center at Greenwich - Greenwich, Connecticut, United States
- Smilow Cancer Hospital Care Center - Guilford - Guilford, Connecticut, United States
- Smilow Cancer Hospital-Hamden Care Center - Hamden, Connecticut, United States
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford, Connecticut, United States
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven, Connecticut, United States
- Yale-New Haven Hospital Saint Raphael Campus - New Haven, Connecticut, United States
- Yale University - New Haven, Connecticut, United States
- Yale-New Haven Hospital North Haven Medical Center - North Haven, Connecticut, United States
- Smilow Cancer Hospital-Orange Care Center - Orange, Connecticut, United States
- Smilow Cancer Hospital-Torrington Care Center - Torrington, Connecticut, United States
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull, Connecticut, United States
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury, Connecticut, United States
- Smilow Cancer Hospital Care Center - Waterford - Waterford, Connecticut, United States
- Veterans Affairs Connecticut Healthcare System-West Haven Campus - West Haven, Connecticut, United States
- Beebe Medical Center - Lewes, Delaware, United States
- Beebe South Coastal Health Campus - Millville, Delaware, United States
- Helen F Graham Cancer Center - Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA - Newark, Delaware, United States
- Christiana Care Health System-Christiana Hospital - Newark, Delaware, United States
- Beebe Health Campus - Rehoboth Beach, Delaware, United States
- Christiana Care Health System-Wilmington Hospital - Wilmington, Delaware, United States
- MedStar Georgetown University Hospital - Washington D.C., District of Columbia, United States
- Holy Cross Hospital - Fort Lauderdale, Florida, United States
- Regional Cancer Center-Lee Memorial Health System - Fort Myers, Florida, United States
- Mayo Clinic in Florida - Jacksonville, Florida, United States
- Lakeland Regional Health Hollis Cancer Center - Lakeland, Florida, United States
- Emory University Hospital Midtown - Atlanta, Georgia, United States
- Emory University Hospital/Winship Cancer Institute - Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital - Atlanta, Georgia, United States
- Saint Alphonsus Cancer Care Center-Boise - Boise, Idaho, United States
- Saint Luke's Cancer Institute - Boise - Boise, Idaho, United States
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell, Idaho, United States
Showing 60 of 429 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →