Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Other
Study Type: Observational
SUMMARY

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date.

• Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial.

• Age ≥ 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

• Adequate organ function

• Life expectancy of \> 90 days as judged by the investigator

• Ability to give informed consent

• Measurable disease by RECIST 1.1

• Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance.

• Fit enough to safely undergo a tumour biopsy as judged by the investigator

• Ability to lie supine for \> 60 minutes

⁃ Patients in the archival cohort must also fulfil the following criteria:

• Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen)

Locations
Other Locations
Canada
Tom Baker Cancer Centre
RECRUITING
Calgary
Cross Cancer Institute
WITHDRAWN
Edmonton
The Ottawa Hospital
ACTIVE_NOT_RECRUITING
Ottawa
BC Cancer - Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Daniel J Renouf, MD
drenouf@bccancer.bc.ca
800-663-3333
Time Frame
Start Date: 2016-10-06
Estimated Completion Date: 2027-12
Participants
Target number of participants: 190
Treatments
Biopsy Cohort
Participants will undergo a tumour biopsy at baseline and an optional tumour biopsy at disease progression.~Participants will undergo serial collection of plasma and serum samples.
Archival Cohort
Genomic analyses will be performed on participants' archival tumour samples.~Participants will undergo serial collection of plasma and serum samples.
Sponsors
Collaborators: American Society of Clinical Oncology, Pancreas Centre BC, Terry Fox Research Institute, BC Cancer Foundation
Leads: British Columbia Cancer Agency

This content was sourced from clinicaltrials.gov