Using Tumour DNA and Proteins to Better Understand How Pancreatic Cancer Responds to Treatment (ACCELERATE)

January 15, 2026 updated by: British Columbia Cancer Agency

Accelerating the Actionability of Treatment in Resected and Locally Advanced Pancreatic Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Participants must meet all of the following criteria prior to Pre-Baseline registration:

  1. Age 18 years or older.
  2. Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
  3. Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
  4. Able to give informed consent for the study-related procedures performed during laparoscopy.

Participants must meet all of the following criteria to be eligible for enrollment in the Main Study:

  1. Age 18 years or older.
  2. Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
  3. Histological and/or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC. Participants without a histological diagnosis of PDAC must undergo confirmatory histological diagnosis prior to treatment start date.
  4. Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
  5. Planned for adjuvant (Resectable and Borderline Resectable Cohorts) or first-line (Locally Advanced Cohort) therapy with FOLFIRINOX or a gemcitabine-based regimen, either as part of routine care or in combination with an investigational agent(s) within another clinical trial. Participants may have received pre-operative therapy.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  7. Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L.
    2. Hemoglobin ≥ 9 g/dL.
    3. Platelets ≥ 75 x 10^9/L.
    4. Prothrombin time test and international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 x Upper Limit of Normal (ULN).
    5. Total bilirubin ≤ 1.5 x ULN. Isolated bilirubin > 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%.
    6. Aspartate aminotransferase (AST) and alanine aminotransferase (AST) ≤ 1.5 x ULN. If liver metastases are present, AST and ALT ≤ 5 x ULN is permitted.
    7. Albumin ≥ 25 g/L.

    8. One of the following:

      • Creatinine ≤ 1.5 x ULN.
      • Calculated creatinine clearance (as calculated by Cockcroft-Gault formula) ≥ 40 mL/min.
      • 24-hour urine creatinine clearance ≥ 40 mL/min.
  8. Life expectancy greater than 90 days as judged by the investigator.
  9. Able to give informed consent for the study procedures defined in this protocol.
  10. Measurable disease by RECIST 1.1. For those in the Resectable and Borderline Resectable Cohorts, measurable disease must be present prior to resection surgery.

Exclusion Criteria:

  1. Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
  2. Currently receiving adjuvant (Resectable and Borderline Resectable Cohorts) or systemic (Locally Advanced Cohort) anti-cancer therapy (chemotherapy or any other anti-cancer agent) with one exception: pre-operative therapy is permitted.
  3. Not fit for chemotherapy as judged by the investigator.
  4. Presence of brain metastases.
  5. Positive pregnancy test.
  6. Unable to comply with the study assessments and procedures defined in this protocol.
  7. Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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 from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (folinic acid (leucovorin), fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) or gemcitabine-based) regimens.
Genetic: Genetic testing
Analyses of the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, and other molecules in the sample.
Procedure: Optional biopsy
Optional collection of tumour tissue and normal tissue after the last dose of treatment.
Procedure: Tissue collection
Collection of tumour tissue and normal tissue from biopsy or standard resection surgery prior to the first dose of treatment.
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 collected from a standard laparoscopy procedure. Blood samples will be collected at several timepoints throughout the study. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Genetic: Genetic testing
Analyses of the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, and other molecules in the sample.
Procedure: Optional biopsy
Optional collection of tumour tissue and normal tissue after the last dose of treatment.
Procedure: Tissue collection
Collection of tumour tissue and normal tissue from biopsy or standard resection surgery prior to the first dose of treatment.
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 throughout the study. Tumour samples may also be collected, if participants agree to optional biopsies. Participants will receive standard chemotherapy (FOLFIRINOX or gemcitabine-based) regimens.
Genetic: Genetic testing
Analyses of the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, and other molecules in the sample.
Procedure: Optional biopsy
Optional collection of tumour tissue and normal tissue after the last dose of treatment.
Procedure: Tissue collection
Collection of tumour tissue and normal tissue from biopsy or standard resection surgery prior to the first dose of treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of comprehensive genomic results returned within 8 weeks of sample collection.
Time Frame: From the date of resection surgery or baseline ctDNA collection until genomic results are available (typically 8 weeks).
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

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) in each study arm, as defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.]
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.]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation
Terry Fox Research Institute

Investigators

  • Principal Investigator: Daniel J Renouf, MD, BC Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

November 28, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

August 26, 2024

First Posted (Actual)

August 28, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H24-01809

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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