Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

NCT02869802 | Recruiting

• 2 other identifiers: H20-02375H16-00291
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of days between biopsy and return of comprehensive genomic results.

  The primary endpoint is the assessment of the feasibility of returning comprehensive genomic results within a clinically meaningful timeframe. Specifically the primary endpoint is return of genomic data by 8 weeks from the time of biopsy. This endpoint will be met if the analysis data is available within 8 weeks for 80% of the first 50 patients whose tumours are successfully sequenced.

  An average of 8 weeks

Secondary Outcomes (5)

• Response Rate

  Up to an average of 1 year

• Disease Control Rate

  Up to an average of 1 year

• Duration of Response

  Up to an average of 1 year

• Progression-Free Survival

  Up to an average of 1 year

• Overall Survival

  Up to an average of 1 year

Other Outcomes (7)

• Engraftment rate of patient-derived xenografts

  5 years

• Success rate of establishing patient-derived organoids

  5 years

• DNA damage repair pathways

  5 years

Study Arms (2)

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.

Procedure: Tumour Biopsy; Other: 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.

Other: Serial Collection of Plasma and Serum Samples

Interventions

Tumour Biopsy PROCEDURE

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.

Biopsy Cohort

Serial Collection of Plasma and Serum Samples OTHER

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.

Archival Cohort; Biopsy Cohort

Eligibility Criteria

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

Study Population

Patients with metastatic PDAC undergoing first-line systemic therapy with either FOLFIRINOX or GP-based regimens.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Terry Fox Research Institute: collaborator
• BC Cancer Foundation: collaborator
• Pancreas Centre BC: collaborator
• American Society of Clinical Oncology: collaborator

Study Sites (4)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

RECRUITING

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

WITHDRAWN

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

ACTIVE NOT RECRUITING

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Related Links

• Integrated Addendum to International Council for Harmonization (ICH) E6(R1): Guideline for Good Clinical Practice ICH E6(R2)

Biospecimen

Retention: SAMPLES WITH DNA

Fresh tumour tissue biopsy samples Archival tumour tissue samples Whole blood samples Plasma samples Serum samples

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 17, 2016
• Study Start: October 6, 2016
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)