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2025-04
2028-12
2031-12
200
NCT06574620
British Columbia Cancer Agency
British Columbia Cancer Agency
INTERVENTIONAL
Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-08-26 | N/A | 2025-02-04 |
2024-08-26 | N/A | 2025-02-06 |
2024-08-28 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Basic Science
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Resectable Cohort Participants with resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be collected f | GENETIC: Genetic testing
PROCEDURE: Optional biopsy
|
| OTHER: Borderline Resectable Cohort Participants with borderline resectable PDAC. Participants will provide tumour, fluid, and blood samples for genetic testing and other analyses. Tumour samples will be collected from standard resection surgery and optional biopsies. Fluid samples will be | GENETIC: Genetic testing
PROCEDURE: Optional biopsy
|
| OTHER: Locally Advanced Cohort Participants with locally advanced PDAC. Participants will provide fluid and blood samples for genetic testing and other analyses. Fluid samples will be collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints | GENETIC: Genetic testing
PROCEDURE: Optional biopsy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | Measure Description | Time Frame |
|---|---|---|
| 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.] |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Daniel J Renouf, MD Phone Number: 604-877-6000 Email: drenouf@bccancer.bc.ca |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
