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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Tumour DNA and Proteins for pancreatic cancer?

Research shows that detecting circulating tumour DNA (ctDNA) in the blood can help predict the return of pancreatic cancer earlier than traditional imaging methods. This suggests that using tumour DNA as part of treatment could potentially improve monitoring and outcomes for patients. ^{1 2 3 4 5}

Is genetic testing for pancreatic cancer safe for humans?

The research does not provide specific safety data for genetic testing in humans, but it focuses on the utility of genetic testing for identifying mutations and guiding treatment in pancreatic cancer patients. ^{1 6 7 8 9}

How does genetic testing for pancreatic cancer differ from other treatments?

Genetic testing for pancreatic cancer is unique because it involves analyzing genetic mutations in the tumor and blood, which can help predict outcomes and guide treatment decisions. This approach is different from traditional treatments as it focuses on identifying specific genetic changes that may offer new therapeutic targets and improve early detection. ^{4 5 7 10 11}

What is the purpose of this trial?

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.

Research Team

Daniel J Renouf, MD

Principal Investigator

BC Cancer

Eligibility Criteria

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.

I am currently on cancer treatment, except for pre-operative therapy.

Positive pregnancy test.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Resectable Cohort Experimental Treatment 2 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 2 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 2 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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Pancreatic Cancer Genomes: Implications for Clinical Management and Therapeutic Development. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Adherence to NCCN Genetic Testing Guidelines in Pancreatic Cancer and Impact on Treatment. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of Comprehensive Genomic Profiling Tests for Patients with Incurable Pancreatic Cancer in Clinical Practice. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical implications of genomic alterations in the tumour and circulation of pancreatic cancer patients. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Longitudinal profiling of circulating tumour DNA for tracking tumour dynamics in pancreatic cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Usefulness of rapid on-site evaluation specimens from endoscopic ultrasound-guided fine-needle aspiration for cancer gene panel testing: A retrospective study. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Profiling tumour heterogeneity through circulating tumour DNA in patients with pancreatic cancer. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Epidemiology and geographic distribution of BRCA1-2 and DNA Damage response genes pathogenic variants in pancreatic ductal adenocarcinoma patients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Prevalence of germ-line mutations in cancer genes among pancreatic cancer patients with a positive family history. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

KRAS mutations in blood circulating cell-free DNA: a pancreatic cancer case-control. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Circulating Tumor DNA Is an Accurate Diagnostic Tool and Strong Prognostic Marker in Pancreatic Cancer. [2023]