Recruiting

Genomic Analysis

Sponsor:

British Columbia Cancer Agency

Code:

NCT02869802

Conditions

Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tumour Biopsy

Serial Collection of Plasma and Serum Samples

Study Details

Brief summary:

Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.

Conditions

Cancer

Pancreatic Cancer

Study ID

NCT02869802

Start date

Oct 6, 2016

Status verified date

Sep, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histological and/or radiological diagnosis of metastatic PDAC. Patients without a histological diagnosis of PDAC must undergo confirmatory tumour biopsy prior to treatment start date.
  • Planned for first-line systemic therapy with FOLFIRINOX or GP, either in routine care or in combination with an investigational agent(s) within a clinical trial.
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function
  • Life expectancy of > 90 days as judged by the investigator
  • Ability to give informed consent
  • Measurable disease by RECIST 1.1
  • Presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist. A minimum of 3 tumour cores must be safely obtainable under CT or US guidance.
  • Fit enough to safely undergo a tumour biopsy as judged by the investigator
  • Ability to lie supine for > 60 minutes

Patients in the archival cohort must also fulfil the following criteria:

  • Archival tumour sample available (either a previous tumour diagnostic biopsy or resection specimen)

Exclusion Criteria:

  • Absence of distant or lymph node metastases. Patients with borderline resectable or locally advanced PDAC are not eligible.
  • Received prior systemic therapy (chemotherapy or any other anti-cancer agent) in the advanced setting. Patients who received adjuvant chemotherapy after surgical resection of early stage disease are eligible.
  • Currently receiving anti-cancer therapy (chemotherapy or any other anti-cancer agent)
  • Not fit for combination chemotherapy as judged by the investigator
  • Presence of brain metastases
  • Female patients with positive pregnancy test
  • Patients who are not safe to include in the study as judged by the investigator for any medical or non-medical reason
  • Unable to comply with study assessments and follow-up

Study Design

Enrollment

190 participants

Anticipated

Interventions and Outcome Measures

Arms

Biopsy Cohort

Participants will undergo a tumour biopsy at baseline and an optional tumour biopsy at disease progression.

Participants will undergo serial collection of plasma and serum samples.

Archival Cohort

Genomic analyses will be performed on participants' archival tumour samples.

Participants will undergo serial collection of plasma and serum samples.

Interventions

Tumour Biopsy

If there is the presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist, a minimum of 3 tumour cores will be obtained under CT or US guidance.

Serial Collection of Plasma and Serum Samples

Participants will undergo serial collection of plasma and serum samples at baseline and every cycle of chemotherapy or every 4 weeks, whichever is longer, until end of study.

Primary outcome measure

  • Number of days between biopsy and return of comprehensive genomic results. [ Time Frame: An average of 8 weeks ]

Central Contacts and Locations

Central contacts

Daniel J Renouf, MD

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

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N2

Contacts

Patricia Tang, MD

403-521-3723Patricia.Tang@albertahealthservices.ca

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Daniel J Renouf, MD

6048776000drenouf@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Keywords

  • Cancer
  • Pancreatic Cancer
  • Advanced Pancreatic Ductal Adenocarcinoma
  • PDAC
  • Genomic Analysis
  • Molecular subtyping

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 2025-09-22.