Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

Inclusion Criteria:

* 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 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