Clinical trial · Observational
MicroRNAs as Bile-based Biomarkers in Pancreaticobiliary Cancers
NCT06258824CI-TRIAL-00074019MIRABILEcompletedClinicalTrials.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)
pancreatic or biliary-tract cancer can be a serious diagnosis, as many patients present too late for surgery. Cancer cells have been found to release small messenger molecules called that regulate cancer genes called microRNAs (miRNAs). The goal of this observational study is to learn about the role of miRNAs from bile and blood samples in patients with pancreatic cancer and bile duct cancer. The main question\[s\] it aims to answer are: * Can this detect patients presenting with jaundice (yellow-skin) undergoing endoscopy? * Can this distinguish between the types of cancer? Participants will have blood and bile samples collected prior to diagnosis and their clinical pathway will be followed up for 6 months.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Biliary Stricture | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallstone Disease | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Small RNA Sequencing and Validation of candidate miRNAs | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Pancreatic Cancer (PDAC)
- description
- A clinical diagnosis of PDAC was defined by results of a multidisciplinary team meeting consisting of at least a consultant hepatopancreaticobiliary surgeon, consultant hepatopancreaticobiliary physician, consultant histopathologist and consultant radiologist. ERCP findings, endoscopic ultrasound findings, biliary brushing cytology, and fine needle aspiration cytology were anonymised and recorded. The combination of a pancreatic mass on radiographic imaging without acute cholangiopathy, and clinical or radiographic progression after ≥12 months of follow-up, or death clinically and radiographically determined to be due to pancreatic cancer. For surgical resection and biopsy specimens, diagnoses and staging were rendered based on standard histo-morphological criteria. For the purposes of analysis, pathological staging was used in preference to clinical staging where possible.
- interventionNames
- Diagnostic Test: Small RNA Sequencing and Validation of candidate miRNAs
- label
- Cholangiocarcinoma (CCA)
- description
- A clinical diagnosis of CCA was defined by radiological criteria according to results of a multidisciplinary team meeting consisting of at least a consultant hepatopancreaticobiliary surgeon, consultant hepatopancreaticobiliary physician, consultant histopathologist and consultant radiologist. ERCP findings, endoscopic ultrasound findings, biliary brushing cytology, and fine needle aspiration cytology were anonymised and recorded. This was also determined based on clinical or radiographic progression after ≥12 months of follow-up, or death clinically and radiographically determined to be due to cancer. For surgical resection and biopsy specimens, diagnoses and staging were rendered based on standard histo-morphological criteria. For the purposes of analysis, pathological staging was used in preference to clinical staging where possible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * Scheduled for clinical reason to undergo an ERCP (endoscopic retrograde cholangiopancreatography). * WHO performance status 0, 1 or 2. * Willing and mentally able to provide written informed consent. * Suspected of having benign pancreaticobiliary disease (e.g. chronic pancreatitis, primary sclerosing cholangitis, common bile duct gallstones (choledocholithiasis), sphincter of Oddi dysfunction); or suspected of having PDAC or BTC. * Presenting with obstructive jaundice and/or an indeterminate biliary stricture. Exclusion Criteria: * Age \<18years old. * Patients undergoing ERCP post-bariatric surgery, hepatico-jejunostomy or Bilroth II . * Pregnancy. * WHO performance status 3 or 4. * Not willing or able to sign informed consent. * Not scheduled for endoscopic procedures for clinical reasons. * No clinical or image data suggestive of pancreaticobiliary disease and need for endoscopic intervention or investigation.
References
Publications (0)
Data not yet available
No reference posted for this study.