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2020-10-04
2021-10-05
2023-11-05
186
NCT04584996
Royal Surrey County Hospital NHS Foundation Trust
Royal Surrey County Hospital NHS Foundation Trust
OBSERVATIONAL
CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers
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.
This first step of this project is a 'discovery experiment' to describe the expression profiles of 8 PDAC tissue samples compared to controls; with subsequent validation of candidate circRNAs: 8 paired samples of PDAC tumour tissue and associated normal pancreatic tissue will be collected at the time of surgery (after the pancreatic tumour is resected). The expression levels of circRNAs will be profiled and the most significantly dysregulated candidate circRNAs will be chosen (also considering other datasets and the current literature in this decision). The second step of this project is a prospective non-interventional observational cohort study to investigate these candidate circRNAs further: The expression of these candidate circRNAs expression levels will be measured longitudinally throughout the clinical timeline of patients with PDAC in blood samples; and in bile, tissue and biopsy samples (when this is safely available after clinical sampling and without additional investigations). This will be compared against control patients with benign biliary disease and other biliary tract cancers. These controls would only be available for blood tests and, if undergoing cholecystectomy, bile. Blood tests will be taken alongside clinical bloods or after anaesthesia for surgical procedures, bile will be taken after removal of the gallbladder for gallstone disease when this is in excess to clinical requirements. The ability of each circRNAs as a diagnostic, prognostic and predictive biomarkers will be described and compared to CA 19-9 (the only biomarker that is currently widely accepted in PDAC). This will first be considered in blood samples and then other patient biomaterials. The final part of the project will be to undertake both computer and laboratory evaluation of candidate circRNAs in order to propose a its molecular relationships and how this may explain and associations described. A Bioinformatical review will give the ability to computationally determine the miRNA-binding capabilities of candidate circRNAs, and the downstream mRNAs regulated. Gene-ontology and KEGG pathway enrichment-analyses of the differentially expressed genes will allow a global-view of the transcriptome under circRNA regulation in PDAC.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-10-06 | N/A | 2021-03-04 |
2020-10-06 | N/A | 2021-03-08 |
2020-10-14 | N/A | 2021-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Pancreatic cancer 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 | |
| : Control 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 |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| circRNAs for diagnosis | To identify a plasma circRNA 'signature' able to diagnose Pancreatic Ductal Adenocarcinoma (PDAC) with superior sensitivity than serum CA 19-9 | 12 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Describe circRNAs expression profile | Define and validate the circRNA expression profile in PDAC and identify dysregulated circRNA candidate(s). | 12 months |
| Diagnostic features of blood circRNAs | Evaluate candidate circRNA expression in blood (plasma) 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 | 12 months |
| circRNAs in other biomaterials | 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 (i.e. surgery and/or chemotherapy). | 30 months |
| Bioinformatics | tilise computer-based analyses to describe the theoretical interactions of candidate circRNAs within transcriptome in human PDAC. | 18 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Kate Penhaligon Phone Number: 01483 688 660 Email: k.penhaligon@nhs.net |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
