Clinical registry of cancers of the biliary tract
| ISRCTN | ISRCTN15141439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15141439 |
| IRAS number | 276732 |
| Secondary identifying numbers | IRAS 276732 |
- Submission date
- 26/08/2020
- Registration date
- 17/09/2020
- Last edited
- 27/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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 December 2030
Who is funding the study?
University of Glasgow (UK)
Who is the main contact?
1. Dr Chiara Braconi, chiara.braconi@glasgow.ac.uk
2. Karen Allan, karen.allan.3@glasgow.ac.uk
Contact information
Scientific
Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
 ORCID ID |
0000-0003-4835-1259 |
|---|---|
| Phone | +44 (0)141 330 3278 |
| chiara.braconi@glasgow.ac.uk |
Public
Glasgow Oncology Clinical Trials Unit (GO CTU)
Partner in CaCTUS - Cancer Clinical Trials Unit Scotland
Level 0
Beatson West of Scotland Cancer Centre
Gartnavel General Hospital
Glasgow
G12 0YN
United Kingdom
| Phone | +44 (0)141 301 7959 (internal 57959) |
|---|---|
| karen.allan.3@glasgow.ac.uk |
Study information
| Study design | Observational longitudinal study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | REGBil: Clinical REGistry and molecular characterisation of Biliary tract cancers |
| Study acronym | Reg-Bil |
| Study objectives | To study overall survival in patients with biliary tract cancers in a prospective fashion. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2019 |
| Completion date | 31/12/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key exclusion criteria | 1. Medical or psychiatric conditions impairing ability to give informed consent |
| Date of first enrolment | 01/09/2020 |
| Date of final enrolment | 30/11/2024 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Glasgow
G12 0YN
United Kingdom
Sponsor information
Hospital/treatment centre
Dykebar Hospital
Grahamston Road
Paisley
PA2 7DE
Scotland
United Kingdom
| Phone | +44 (0)141 301 9917 |
|---|---|
| joanne.mcgarry@ggc.scot.nhs.uk | |
| Website | http://www.nhsggc.org.uk/ |
"ROR" |
https://ror.org/05kdz4d87 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/3031 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
27/12/2023: The following changes have been made:
1. The overall study end date has been changed from 31/08/2024 to 31/12/2030 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 01/09/2025 to 31/12/3031.
21/12/2023: Contact details updated. The recruitment end date was changed from 30/08/2024 to 30/11/2024.
09/09/2020: Trial's existence confirmed by South West - Frenchay Research Ethics Committee.
