Clinical trial · Interventional
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
NCT03855800CI-TRIAL-00113374recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreas Cyst | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood, stool, pancreatic juice and cyst fluid collection | Diagnostic Test | — | UNRESOLVED |
| Endoscopy Exam | Procedure | — | UNRESOLVED |
| Pancreatic Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Clinical Follow-up
- description
- 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
- interventionNames
- Diagnostic Test: Blood, stool, pancreatic juice and cyst fluid collection
- Procedure: Endoscopy Exam
- type
- OTHER
- label
- Surgical
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.