MicroRNAs as Bile-based Biomarkers in Pancreaticobiliary Cancers (NCT06258824) | Clinical Trial Compass
CompletedNot Applicable
MicroRNAs as Bile-based Biomarkers in Pancreaticobiliary Cancers
United Kingdom229 participantsStarted 2018-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic Value as measured by Area under the Curve (AUC) for candidate miRNAs