Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment
NCT Number: NCT06574620
Acronym: ACCELERATE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pancreatic Ductal Adenocarcinoma|Resectable Pancreatic Ductal Adenocarcinoma|Borderline Resectable Pancreatic Ductal Adenocarcinoma|Locally Advanced Pancreatic Ductal Adenocarcinoma
Interventions: GENETIC: Genetic testing|PROCEDURE: Optional biopsy
Sponsor: British Columbia Cancer Agency
Collaborators: Terry Fox Research Institute|BC Cancer Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10
Completion Date: 2031-12
Locations: BC Cancer, Vancouver, British Columbia, V5Z 4E6, Canada

Summary:
The goal of this study is to learn if the genetic information and proteins from tumours can help treat pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are:

* Is it feasible to obtain genetic test results within a timeframe that can help inform treatment decisions for individuals with PDAC?
* Can the genetic test results provide information about how a tumour will respond to or resist treatment?

Participants will:

* Receive standard chemotherapy to treat their cancer.
* Provide samples of their blood, tissue, and fluid for genetic testing.
* Visit the clinic every 4 weeks for check-ups and tests.
* Complete questionnaires every 12 weeks.

Primary Outcome Measures: Frequency of comprehensive genomic results returned within 8 weeks of sample collection., The percentage of participants with comprehensive genomic results for their baseline tumour tissue and/or circulating tumour deoxyribonucleic acid (ctDNA) within 8 weeks of their collection., From the date of resection surgery or baseline ctDNA collection until genomic results are available (typically 8 weeks).
Secondary Outcome Measures: Overall response rate (ORR) in each study arm, as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, The proportion of participants in each study arm who have a complete response (CR) or partial response (PR) to treatment, as defined by RECIST 1.1., From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.|Disease control rate in each study arm, as defined by RECIST 1.1, The proportion of participants in each study arm who have a complete response (CR), partial response (PR), or stable disease (SD) to treatment, as defined by RECIST 1.1., From the date of the baseline scan (within 28 days of first dose) until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.|Duration of response (DoR) in each study arm, as defined by RECIST 1.1, The number of days between the first date of complete response (CR) or partial response (PR) and the earliest date of disease recurrence/progression or death due to any cause., From the first date of CR or PR until the first date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.|Progression-free survival (PFS) in each study arm from the initiation of chemotherapy, The number of days from the first dose of chemotherapy until the date of progressive disease (PD), as defined by RECIST 1.1, for participants in each study arm., From the date of first dose of chemotherapy until the date of confirmed progression, withdrawal, date of death, or end of study, whichever comes first, assessed up to 72 months.|Overall survival (OS) in each study arm from the initiation of chemotherapy, The number of days from the initiation of chemotherapy that participants survive in each study arm., From the date of first dose of chemotherapy until the date of death or end of study, whichever comes first, assessed up to 72 months.]