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Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

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Descriptive Information
Brief Title † Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
Official Title † Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
Brief 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.
Detailed Description This is a prospective non-randomized study of patients with metastatic pancreatic ductal adenocarcinoma (PDAC) undergoing first-line systemic chemotherapy with either FOLFIRINOX or GP-based regimens, where tumour samples, baseline and serial blood and urine samples and standardized clinical and radiological assessments will be obtained. Patients planned for treatment with an investigational agent(s) within a clinical trial using either FOLFIRINOX or GP as the chemotherapy backbone will also be eligible, as long other eligibility criteria for the study are met. A total of 120 patients will be recruited over 3 years. Patients will undergo fresh tumour biopsy at study enrolment for comprehensive molecular characterization (biopsy cohort). Patients who are unable to undergo biopsy but fulfill all other eligibility criteria will comprise the archival cohort, where limited genomic analyses will be performed on archival tumour samples. Patients with a radiological diagnosis of metastatic PDAC without a confirmatory histological diagnosis may be eligible; in these cases, tumour biopsy for establishing a pathological diagnosis will be given first priority. Remaining tumour samples will be used for research purposes only after the diagnosis of PDAC has been established. In the rare event (
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Number of days between biopsy and return of comprehensive genomic results.
Secondary Outcome Measure † Response Rate
Condition † Cancer Pancreatic Cancer
Intervention † ProcedureTumour Biopsy
Study Arms / Comparison Groups Biopsy Cohort Participants will undergo a tumour biopsy. Participants will undergo serial collection of plasma, serum and urine samples. Archival Cohort Genomic analyses will be performed on participants' archival tumour samples. Participants will undergo serial collection of plasma, serum and urine samples.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 120
Start Date † September 2016
Completion Date September 2021
Primary Completion Date September 2019
Eligibility Criteria † Inclusion Criteria: - Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy. - 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 - ECOG (Eastern Cooperative Oncology Group) 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 Patients in the biopsy cohort must also fulfil the following criteria: - 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 Criteria: - 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Daniel J Renouf, MD, 6048776000, drenouf@bccancer.bc.ca
Location Countries † Canada
Administrative Information
NCT ID † NCT02869802
Organization ID H16-00291
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † British Columbia Cancer Agency
Collaborators †† Terry Fox Research Institute
Investigators † Principal Investigator: Daniel J Renouf, MD, British Columbia Cancer Agency
Information Provided By
Verification Date April 2017
First Received Date † August 9, 2016
Last Updated Date April 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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