Plain English Summary
Background and study aims
Biliary Tract Cancers (BTC) are tumours arising from the lining of bile ducts. The subtypes of BTCs have similarities but also important differences that can affect their clinical behaviour. The incidence of BTC is increasing all around the world with regional differences in the distribution of subtypes according to risk factors. The aim of this study is to collect clinical data from patients with a diagnosis of BTC in order to define the characteristics and the overall survival in this population.
Who can participate?
Patients aged over 18 years old with a diagnosis of BTC from 2020 to 2024
What does the study involve?
The study involves collecting clinical information on the course of the disease and the response to different treatments. There is an optional choice to provide a number of blood, urine, bile and tissue samples for the duration of treatment and follow-up.
What are the possible benefits and risks of participating?
There are no specific risks or benefits to participants.
Where is the study run from?
Beatson West of Scotland Cancer Centre (UK)
When is the study starting and how long is it expected to run for?
October 2019 to August 2024
Who is funding the study?
University of Glasgow (UK)
Who is the main contact?
1. Dr Chiara Braconi
chiara.braconi@glasgow.ac.uk
2. Michaela Rodger
michaela.rodger@glasgow.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Chiara Braconi
ORCID ID
http://orcid.org/0000-0003-4835-1259
Contact details
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
+44 (0)141 330 3278
chiara.braconi@glasgow.ac.uk
Type
Public
Additional contact
Ms Michaela Rodger
ORCID ID
Contact details
Cancer Research UK Clinical Trials Unit
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
+44 (0)141 301 9917
michaela.rodger@glasgow.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
IRAS 276732
Study information
Scientific title
REGBil: Clinical REGistry and molecular characterisation of Biliary tract cancers
Acronym
Reg-Bil
Study hypothesis
To study overall survival in patients with biliary tract cancers in a prospective fashion.
Ethics approval
Approved 02/07/2020, South West - Frenchay Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol. BS1 2NT; UK; +44 (0)207 1048028; frenchay.rec@hra.nhs.uk), ref: 20/SW/0054
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Biliary tract cancers
Intervention
At study entry, patients will be asked to give their consent for the team to collect their clinical information on the course of their disease. They will also be asked to provide blood, urine, bile and tissue samples for development of markers of response to drug therapy and generation of mini-tumours in the lab. These samples will be collected over the treatment and potentially up to 5 years from study entry.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Overall survival (OS) collected from patient notes up to 5 years from time of diagnosis
Secondary outcome measures
Collected from patient notes up to 5 years from time of diagnosis:
1. Disease-free survival (DFS) in patients undergoing radical surgery
2. Chemotherapy outcomes with each line of therapy (response rate, progression-free survival)
3. Proportion, DFS, and OS of subtypes of biliary tract cancers
4. DFS and OS according to subgroups (grouped in intrahepatic and extrahepatic BTC)
Exploratory outcome measures:
1. Feasibility of organoids generation from BTC assessed using fresh tumour tissue at baseline and at time of progression
2. Presence and absolute quantities of circulating DNA, circulating microRNA and other relevant biomarkers measured using digital PCR, every 3 months during the course of treatment and at progression
3. Circulating DNA in bile measured using sequencing technologies at baseline
4. Potential biomarkers of BTC measured using sequencing at baseline
5. Circulating and tissue based biomarkers in BTC measured using metabolomics and proteomic approaches every 3 months during the course of treatment and progression
Overall trial start date
01/10/2019
Overall trial end date
31/08/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 years or older
2. Patients with radiological or cytological/histological diagnosis of BTC, who have been diagnosed and/or treated at NHS Greater Glasgow and Clyde
3. Informed written consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Medical or psychiatric conditions impairing ability to give informed consent
Recruitment start date
01/09/2020
Recruitment end date
30/08/2024
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde
Sponsor details
Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
United Kingdom
+44 (0)141 301 9917
joanne.mcgarry@ggc.scot.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
University of Glasgow
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/09/2025
Participant level data
Other
Basic results (scientific)
Publication list