Clinical trial · Observational
CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers
- 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)
1. Define the circRNA expression profile in PDAC and identify dysregulated circRNA candidates. These will be validated in further tissue samples. 2. Evaluate candidate circRNA Expression in blood (plasma samples) as a clinically relevant diagnostic biomarker; expanding on the primary objective to include other diagnostic features such as specificity, area under the receiver operator curve, positive predictive value and negative predictive value. 3. Explore the expression of candidate circRNAs and related molecules in patient biomaterials (including tissue, blood, bile and biopsy samples) as biomarkers for diagnosis; prognostication; association with clinico-pathologic features and survival outcomes; and their ability to predict/monitor treatment response e.g. surgery and/or chemotherapy. 4. Utilise computer-based analyses to describe the theoretical interactions of candidate circRNAs within the full complement of RNA and related molecules produced by the tumour cells, called the 'transcriptome', in human PDAC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Pancreatic cancer
- description
- Patients being evaluated at MDT for suspected Pancreatic Ductal Adenocarcinoma (PDAC), via radiological test (e.g. endoscopic ultrasound (EUS), endoscopic retrograde cholangiography (ERCP), cross-sectional imaging), serum tumour marker (i.e. CA 19-9), or other diagnostic procedure
- label
- Control
- description
- Patients diagnosed and/or due to undergo surgery for benign pathology (e.g. gallstones, chronic pancreatitis, etc); or patients with a diagnosis of a pre-malignant lesion (e.g. pancreatic intraductal papillary mucinous neoplasm); Pancreatic Neuroendocrine Tumour, or a Biliary Tract Cancer (i.e. cholangiocarcinoma; gallbladder cancer; ampullary cancer)
Primary outcomes (1)
- measure
- circRNAs for diagnosis
- timeFrame
- 12 months
- description
- To identify a plasma circRNA 'signature' able to diagnose Pancreatic Ductal Adenocarcinoma (PDAC) with superior sensitivity than serum CA 19-9
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants capable of giving informed consent * Aged \>18 years Exclusion Criteria: * Unwilling or unable to provide written informed consent * Non-English speaking * Known to be pregnant * Aged \<18 years * Known diagnosis of HIV or Hepatitis B/C virus
References
Publications (0)
Data not yet available