NCT04239573 Comparing the Clinical Impact of Pancreatic Cyst Surveillance Programs and Associated Biomarkers
| NCT ID | NCT04239573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ECOG-ACRIN Cancer Research Group |
| Condition | Pancreatic Neoplasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 770 participants |
| Start Date | 2020-06-16 |
| Primary Completion | 2034-11-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 770 participants in total. It began in 2020-06-16 with a primary completion date of 2034-11-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
David S Weinberg
PRINCIPAL INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Frequently Asked Questions
Who can join the NCT04239573 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Pancreatic Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04239573 currently recruiting?
Yes, NCT04239573 is actively recruiting participants. Visit ClinicalTrials.gov or contact ECOG-ACRIN Cancer Research Group to inquire about joining.
Where is the NCT04239573 trial being conducted?
This trial is being conducted at Birmingham, United States, Mobile, United States, Anchorage, United States, Anchorage, United States and 11 additional locations.
Who is sponsoring the NCT04239573 clinical trial?
NCT04239573 is sponsored by ECOG-ACRIN Cancer Research Group. The principal investigator is David S Weinberg at ECOG-ACRIN Cancer Research Group. The trial plans to enroll 770 participants.