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

NCT06574620 | Recruiting

• 1 other identifier: H24-01809
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Locally Advanced Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall response rate (ORR) in each study arm, as defined by Response Evaluation Criteria in Solid Tumours (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

  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

  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

  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

  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.]

Study Arms (3)

Resectable Cohort

OTHER

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; Procedure: Optional biopsy; Procedure: Tissue collection

Borderline Resectable Cohort

OTHER

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; Procedure: Optional biopsy; Procedure: Tissue collection

Locally Advanced Cohort

OTHER

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; Procedure: Optional biopsy; Procedure: Tissue collection

Interventions

Genetic testing GENETIC

Analyses of the deoxyribonucleic acid (DNA), ribonucleic acid (RNA), proteins, and other molecules in the sample.

Borderline Resectable Cohort; Locally Advanced Cohort; Resectable Cohort

Optional biopsy PROCEDURE

Optional collection of tumour tissue and normal tissue after the last dose of treatment.

Borderline Resectable Cohort; Locally Advanced Cohort; Resectable Cohort

Tissue collection PROCEDURE

Collection of tumour tissue and normal tissue from biopsy or standard resection surgery prior to the first dose of treatment.

Borderline Resectable Cohort; Locally Advanced Cohort; Resectable Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria prior to Pre-Baseline registration:
• Age 18 years or older.
• Histological or radiological diagnosis of resectable, borderline resectable, or locally advanced PDAC.
• Medically fit and planned to undergo laparoscopic procedure as part of standard of care.
• 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:
• Age 18 years or older.
• Enrolled in the Personalized Oncogenomics (POG) Program at BC Cancer.
• 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.
• Medically fit to undergo surgical resection of the primary lesion(s) as judged by the investigator (Resectable and Borderline Resectable Cohorts only).
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Adequate organ function as defined by the following laboratory results obtained within 28 days prior to enrollment date:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
• Hemoglobin ≥ 9 g/dL.

You may not qualify if:

• Presence of distant or lymph node metastases. Individuals with metastatic PDAC are not eligible.
• 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.
• Not fit for chemotherapy as judged by the investigator.
• Presence of brain metastases.
• Positive pregnancy test.
• Unable to comply with the study assessments and procedures defined in this protocol.
• Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.

Sponsors & Collaborators

• Terry Fox Research Institute: collaborator
• BC Cancer Foundation: collaborator
• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

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MeSH Terms

Interventions

Genetic Testing; Tissue Banks

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Biological Specimen Banks; Health Facilities

Study Officials

• Daniel J Renouf, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel J Renouf, MD

CONTACT

800-663-3333; drenouf@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: November 28, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

CA (1)