NCT03419247

Brief Summary

This is a study where fresh tumor tissue and blood samples will be collected from patients with advanced biliary tract cancer who will be undergoing 1st line therapy with gemcitabine or fluorouracil (5-FU) regimens to see how useful it is to look for changes and characteristics in genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour to find characteristics that may be useful in choosing treatments for patients in the future.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

December 7, 2017

Last Update Submit

March 30, 2021

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of participants with gene testing data available at 8 weeks from baseline tumor biopsy.

    8 Weeks

Secondary Outcomes (6)

  • Disease control rate

    4 years

  • Progression-free survival rate

    4 years

  • Overall survival rate

    4 years

  • Genomic predictors of response to chemotherapy identified

    4 years

  • Germline mutations of hereditary risk factors

    4 years

  • +1 more secondary outcomes

Study Arms (1)

Tumor tissue and blood sample collection

EXPERIMENTAL
Procedure: Fresh tumor tissue biopsyProcedure: Blood drawProcedure: Archival tumor tissue collection

Interventions

Fresh tumor tissue biopsyPROCEDURE

A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.

Tumor tissue and blood sample collection
Blood drawPROCEDURE

Blood will be taken by a needle from a vein.

Tumor tissue and blood sample collection
Archival tumor tissue collectionPROCEDURE

A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.

Tumor tissue and blood sample collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have a histological or radiological diagnosis of inoperable or metastatic biliary tract cancer (BTC).
  • Patient must have a tumor lesion that is amenable to a core needle biopsy as judged by a staff radiologist.
  • Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
  • Patients must be fit enough to safely undergo a tumor biopsy as judged by the investigator.
  • Eastern Cooperative Group (ECOG) performance status ≤ 1 (Karnofsky ≥60%).
  • Life expectancy of greater than 90 days, as judged by the investigator.
  • Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
  • Patients must undergo systemic treatment with gemcitabine or 5-FU based regimens as first line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
  • Ability to understand and willing to sign a written informed consent document.

You may not qualify if:

  • Patients with one or more contraindications to tumor biopsy.
  • Patients who have had prior systemic treatment (chemotherapy or any other anti-cancer agent) in the advanced setting.
  • Patients who are currently on anti-cancer treatment including chemotherapy.
  • Patients with known brain metastases are excluded from participation in this clinical study.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jennifer J Knox, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2017

First Posted

February 1, 2018

Study Start

January 1, 2020

Primary Completion

January 2, 2022

Study Completion

January 2, 2023

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share