Detecting cancer risk in pancreatic cysts using new tests
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
This study is testing new blood and fluid tests to see if they can help identify cancer risks in people with certain types of pancreatic cysts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT03855800 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of new biomarkers found in blood, stool, pancreatic cyst fluid, and pancreatic juice for diagnosing malignant or pre-malignant changes in pancreatic cysts. Participants with Fukuoka Worrisome or Fukuoka High Risk pancreatic cysts will be enrolled and assigned to either Immediate Surgery or Clinical Follow-up groups based on their clinical management. Specimens will be collected from participants to assess the presence of these biomarkers and their correlation with cyst malignancy. The study is designed to improve diagnostic accuracy and patient outcomes in managing pancreatic cysts.
Who should consider this trial
Good fit: Ideal candidates include patients with pancreatic cystic lesions classified as Fukuoka worrisome or high-risk.
Not a fit: Patients with a prior history of pancreatic cancer or those currently diagnosed with other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate detection of cancerous changes in pancreatic cysts, potentially improving patient outcomes.
How similar studies have performed: Other studies have explored similar biomarker approaches in cancer detection, showing promising results, but this specific application in pancreatic cysts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnant and/or nursing * Incarceration * Imaging showing possible pancreatic cancer * Prior history of pancreatic cancer or pancreatic surgery * History of receiving systemic chemotherapy or abdominal radiation within the last 5 years * Previous therapy for a pancreatic cystic lesion * History of pancreatic necrosis * Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years
Where this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Shounak Majumder, MD — Mayo Clinic
- Study coordinator: IN-CYST Team
- Email: rstincyststudy@mayo.edu
- Phone: 1-833-250-5364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.