Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
British Columbia Cancer Agency
190 participants
Oct 6, 2016
OBSERVATIONAL
Conditions
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
Inclusion Criteria13
- 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)
Exclusion Criteria8
- Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible.
- Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
- Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent)
- Not fit for combination chemotherapy as judged by the investigator
- Presence of brain metastases
- Female patients with positive pregnancy test
- Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason
- Unable to comply with study assessments and follow-up
Interventions
If there is the presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist, a minimum of 3 tumour cores will be obtained under CT or US guidance.
Participants will undergo serial collection of plasma and serum samples at baseline and every cycle of chemotherapy or every 4 weeks, whichever is longer, until end of study.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02869802