CIRcular and Non-coding RNAs as Clinically USeful Biomarkers in Pancreaticobiliary Cancers

NCT04584996 | Unknown DMC

• 1 other identifier: IRAS 277406
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Define the circRNA expression profile in PDAC and identify dysregulated circRNA candidates. These will be validated in further tissue samples.
2. 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. 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. 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

Pancreatic Cancer; Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Describe circRNAs expression profile

  12 months

• Diagnostic features of blood circRNAs

  12 months

• circRNAs in other biomaterials

  30 months

• Bioinformatics

  18 months

Study Arms (2)

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 other diagnostic procedure

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 Tumour, or a Biliary Tract Cancer (i.e. cholangiocarcinoma; gallbladder cancer; ampullary cancer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Participants capable of giving informed consent
• Aged \>18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Surrey County Hospital NHS Foundation Trust: lead

Study Sites (1)

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Diseases

Study Officials

• C A Limb, MBBS MRes

  The Royal Surrey NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kate Penhaligon

CONTACT

01483 688 660; k.penhaligon@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: October 4, 2020
• Primary Completion: October 5, 2021
• Study Completion: November 5, 2023
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)