Clinical registry of cancers of the biliary tract

REGBil: Clinical REGistry and molecular characterisation of Biliary tract cancers

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15141439

Enrollment

150

Registered

2020-09-17

Start date

2020-09-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancers Cancer Malignant neoplasm of other and unspecified parts of biliary tract

Interventions

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 an

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Medical or psychiatric conditions impairing ability to give informed consent

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) collected from patient notes up to 5 years from time of diagnosis	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Scotland, United Kingdom

Contacts

Public ContactKaren Allan

karen.allan.3@glasgow.ac.uk+44 (0)141 301 7959 (internal 57959)

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026