Tumour and germline molecular profiling for Biliary Tract Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Biliary Tract CancerTumour and germline molecular profiling - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is investigating the feasibility of returning whole genome sequencing results within 8 weeks of a biliary tract cancer tumor biopsy, in order to identify actionable molecular alterations that may improve clinical outcomes.

Eligible Conditions
  • Biliary Tract Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 4 years

2 years
Number of participants with tumour whole genome sequencing returned within 8 weeks
4 years
Disease control rate
Number of patients in whom at least 1 actionable mutation is identified
Therapeutic procedure
Overall survival rate
Progression-free survival rate

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Individuals with advanced biliary tract cancer
1 of 1

Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Tumour and germline molecular profiling · No Placebo Group · N/A

Individuals with advanced biliary tract cancer
Other
Experimental Group · 1 Intervention: Tumour and germline molecular profiling · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
399 Previous Clinical Trials
125,482 Total Patients Enrolled
Cancer Research SocietyUNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are fit to undergo a tumour biopsy as judged by the investigator.
Patients must have a measurable lesion by RECIST 1.
You have a life expectancy of greater than 90 days.
You are able to understand and willing to sign a written informed consent document.
You have a histological or radiological diagnosis of inoperable or metastatic BTC.
You have a tumour that is amenable to a core needle biopsy.