Recruiting

Genetic Testing

Sponsor:

British Columbia Cancer Agency

Code:

NCT06574620

Conditions

Pancreatic Ductal Adenocarcinoma

Resectable Pancreatic Ductal Adenocarcinoma

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genetic testing

Optional biopsy

Tissue collection

Study Details

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

Resectable Pancreatic Ductal Adenocarcinoma

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Locally Advanced Pancreatic Ductal Adenocarcinoma

Study ID

NCT06574620

Start date

Nov 28, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Genetic testing

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

Optional biopsy

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

Tissue collection

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

Primary outcome measure

  • 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). ]

Central Contacts and Locations

Central contacts

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-01-16.