Genetic Testing for Pancreatic Cancer

(ACCELERATE Trial)

Overseen By Daniel J Renouf, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: British Columbia Cancer Agency

Must be taking: Chemotherapy

Disqualifiers: Metastases, Brain metastases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic information from pancreatic cancer tumors can guide treatment decisions and predict tumor reactions to treatments. Participants will undergo standard chemotherapy and provide blood, tissue, and fluid samples for genetic analysis, including the study of tumor DNA and proteins. The study seeks individuals diagnosed with pancreatic ductal adenocarcinoma (PDAC) who plan to undergo standard surgical and chemotherapy treatments. Participants should be able to undergo a routine laparoscopic procedure and provide informed consent. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could personalize future pancreatic cancer treatments.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you will receive standard chemotherapy as part of the study, so it's best to discuss your current medications with the study team.

What prior data suggests that this genetic testing is safe for pancreatic cancer patients?

Research shows that using genetic information and proteins from tumors to guide treatment decisions for pancreatic cancer holds promise. Studies have found that analyzing tumor DNA and proteins can help predict a tumor's response to treatment.

This approach has been tested in studies examining circulating tumor DNA (ctDNA) and protein markers. These studies discovered that using both can improve cancer detection and management.

Regarding safety, collecting blood and tissue samples is generally well-tolerated, with minimal risk. Procedures like standard surgery and laparoscopy (a method to examine the abdomen) are routine and considered safe.

While the specific treatment under consideration isn't yet approved for this exact use, these techniques have been tested in other situations with good safety records. For those considering joining a clinical trial, it's reassuring to know that these methods have been used in research with careful monitoring and are generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores genetic testing to better understand pancreatic cancer, which could lead to more personalized treatment options. Unlike standard care, which typically involves chemotherapy like FOLFIRINOX or gemcitabine, this trial focuses on analyzing tumor DNA and proteins. By collecting samples from tumors, fluids, and blood, researchers aim to uncover specific genetic markers that could predict how patients respond to treatment. This approach has the potential to tailor therapies more effectively, offering hope for improved outcomes in a condition that is notoriously challenging to treat.

What evidence suggests that genetic testing is effective for pancreatic cancer?

This trial will involve genetic testing for pancreatic ductal adenocarcinoma (PDAC) across different participant cohorts. Research has shown that genetic testing could aid in treating PDAC. Studies have found that up to 25% of pancreatic cancers possess specific genetic changes that treatments can target. These changes affect the DNA repair system, and when disrupted, cancer cells may become more sensitive to certain therapies. Additionally, researchers have created a protein-based model to predict a patient's response to treatment. Understanding the genetic and protein makeup of a tumor could lead to more effective treatment strategies for people with PDAC. ^{2 5 6 7 8}

Who Is on the Research Team?

Daniel J Renouf, MD

Principal Investigator

BC Cancer

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic ductal adenocarcinoma (PDAC) who are receiving standard chemotherapy. They must be willing to provide blood, tissue, and fluid samples for genetic testing and attend clinic visits every 4 weeks.

Inclusion Criteria

Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.

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

I am set to receive FOLFIRINOX or gemcitabine as my first treatment.

Exclusion Criteria

I have been deemed unfit for chemotherapy.

Positive pregnancy test.

Unable to comply with the study assessments and procedures defined in this protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard chemotherapy and provide samples for genetic testing

8 weeks

Clinic visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 months

What Are the Treatments Tested in This Trial?

Interventions

• Tumour DNA and Proteins

Trial Overview The study aims to determine if using genetic information and proteins from tumors can predict how PDAC responds to treatment. It involves regular check-ups, questionnaires every 12 weeks, and providing samples during standard chemo treatment.

How Is the Trial Designed?

Group I: Resectable Cohort Experimental Treatment 3 Interventions

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.

Group II: Locally Advanced Cohort Experimental Treatment 3 Interventions

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.

Group III: Borderline Resectable Cohort Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

British Columbia Cancer Agency

Lead Sponsor

Trials

181

Recruited

95,900+

Terry Fox Research Institute

Collaborator

Trials

11

Recruited

1,600+

BC Cancer Foundation

Collaborator

Trials

20

Recruited

8,600+

Citations

1. nature.com nature.com/articles/s41598-025-00517-1

Evaluation of tumor targets selected from public genomic ... Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with a 5-year survival rate of approximately 5–7%, and complete surgical ...

2. ascopubs.org ascopubs.org/doi/10.1200/PO.19.00115

Outcomes in Patients With Pancreatic Adenocarcinoma ... Up to 25% of pancreatic adenocarcinomas (PDACs) harbor mutations in the homologous recombination DNA damage response (HR-DDR) pathway.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1424390323018331

A protein-based prognostic model for pancreatic ductal ... Our protein-based prognostic model for PDAC, along with six signature proteins, might aid in predicting PDAC prognosis and therapeutic targets.

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2820691

Pancreatic Cancer Surveillance and Survival of High-Risk ... While the overall survival (OS) for individuals with PDAC has improved in recent years, it remains poor, with approximately 11% alive 5 years after diagnosis.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8265372/

Circulating Tumor DNA‐Based Testing and Actionable ... With this study, we sought to characterize the ctDNA genomic alteration landscape in patients with advanced PDAC with a focus on actionable findings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5528974/

Clinical applications of circulating tumor DNA and circulating ... Pancreatic cancer accounts for only 3% of all cancers, but is responsible of 7% of cancer deaths (Jemal et al., 2011). The American Cancer Society estimates ...

7. cell.com cell.com/cell/fulltext/S0092-8674(23)00142-3

Pancreatic cancer: Advances and challenges Human pancreatic cancer tumors are nutrient poor and tumor cells actively scavenge extracellular protein. Cancer Res. 2015; 75:544-553.

8. pnas.org pnas.org/doi/10.1073/pnas.1704961114

Combined circulating tumor DNA and protein biomarker ... In this study, we show how combining mutations in circulating tumor DNA (ctDNA) with protein markers can result in a screening test with improved sensitivity ...