Condition category
Cancer
Date applied
26/08/2020
Date assigned
17/09/2020
Last edited
15/09/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.nhsggc.org.uk/

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

Publication citations

Additional files

Editorial Notes

09/09/2020: Trial's existence confirmed by South West - Frenchay Research Ethics Committee.