MicroRNAs as Bile-based Biomarkers in Pancreaticobiliary Cancers

NCT06258824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 229

Last updated 2024-02-14

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Small RNA Sequencing and Validation of candidate miRNAs

Samples were prepared for small RNA sequencing using Qiagen's QIAseq small RNA Library Prep kit, quality controlled using an Agilent Bioanalyzer 2100 and sequenced on an NextSeq 500 system (Illumina, San Diego, USA) using the default single-end 75 base pair protocol to include integrated unique molecular indices (UMIs). Validation was undertaken using Quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) either using target-specific stem-loop primer assays (TaqMan) or universal reverse transcription (RT) and locked nucleic acid (LNA) enhanced specific primers with SYBR green I assay detection

Sponsors & Collaborators

  • Royal Surrey County Hospital NHS Foundation Trust

    collaborator OTHER
  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER
  • Imperial College London

    lead OTHER

Principal Investigators

  • Adam E Frampton, MB BS FRCS PhD · Imperial College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-03-11
Completion
2020-07-27

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06258824 on ClinicalTrials.gov