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Active, not recruitingNCT05927298ProsperPancUpdated Feb 20, 2026

Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

An observational study in Pancreas Cancer, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University Health Network, Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study summary

This is a prospective, multi-centre, translational and observational study. Two cohorts of patients with pancreatic ductal adenocarcinoma (PDAC) are eligible to enroll 1) Upfront resectable PDAC 2) Advanced (unresectable PDAC or metastatic). Patients will have tissue either at resection or from a biopsy at enrolment processed for whole genome sequencing, RNA sequencing and for establishment of patient derived organoids (PDOs). Background epidemiological history and outcome data will be prospectively annotated. Serial blood and stool samples will be collected for exploratory analyses. All electronic medical record information will also be collected. Data will be used to determine if an integrated correlative analysis of whole genome sequencing/RNAsequencing (WGS/RNAseq) and PDOs in the enrolled population will increase the number of patients receiving a precision-matched treatment in Ontario

Read the detailed description

This study is being done to answer the following question: Can creating 3D models using tumour samples and looking at genetic information from pancreatic ductal adenocarcinoma (PDAC) tumours, help us to provide more patients with a specific, personalized treatment? Two groups of patients with PDAC are eligible to enroll 1) PDAC patients that will go straight to surgery 2) PDAC patients where the disease is either too advanced for a surgical option, or the disease has spread to other areas in the body. Patients will have tumour tissue taken either during their surgery or from a biopsy at enrolment. Background history, outcome data, questionnaires, series of blood draws and stool samples will be collected for analyses. All electronic medical record information will also be collected.

Researchers are looking for better ways of understanding and treating pancreatic cancer by looking to see how useful it is to know about changes and characteristics in the genes in the tumour (molecules that contain instructions for the development and functioning of the cells). Results from analyzed data may be useful in choosing treatments for enrolled patients and for patients in the future. Patients current treatment plan will not change if they choose to take part in this study.

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Conditions studied

  • Pancreas Cancer
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In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

  1. Upfront resectable PDAC not receiving neoadjuvant chemotherapy (Immunotherapy only regimens are eligible)
  2. Advanced (unresectable or metastatic) PDAC suitable for systemic therapy.

Inclusion criteria

  1. Patients must have either upfront resectable PDAC or advanced (unresectable or metastatic) PDAC (borderline PDAC and those planned for neoadjuvant chemotherapy excluded)
  2. Patients with a histological or radiological diagnosis of pancreatic ductal adenocarcinoma (PDAC). For patients awaiting histological confirmation, tissue obtained at study enrolment or can suffice. For those patients who undergo a resection, surgical tissue will be used.
  3. For patients enrolling with resectable PDAC (cohort 1) - the definition of resectability will be according to NCCN guidelines and the patient must be planned for a surgery first approach.
  4. For patients with advanced PDAC (cohort 2), all stages are eligible including locally advanced unresectable, first-line metastatic, second-line (or beyond) metastatic.
  5. In advanced PDAC patients (cohort 2) where a single lesion is to be biopsied, the lesion should be amenable to a core needle biopsy as judged by a staff radiologist. A minimum of 4 to 6 x 18 Gauge (G) good quality tumour cores must be safely obtainable under CT or US guidance.
  6. Patients must have a life expectancy of ≥ 6 months
  7. ECOG 0-1
  8. Patient must be suitable for systemic therapy
  9. Patients should have organ function deemed sufficiently adequate to receive systemic therapy

Exclusion criteria

Exclusion Criteria:

  1. Certain histologies are excluded: colloid, high grade neuroendocrine;
  2. For patients enrolling in cohort 2 - Patients without a tumour lesion amenable to biopsy or with tumour lesions that are not safe for sampling a minimum of 4 to 6 x 18G good quality tumour cores by image guided core needle biopsy as judged by a staff radiologist.
  3. Patients who are not fit enough to undergo a tumour biopsy for any reason as judged by the investigator; this includes patients who cannot stop anticoagulation therapy.
  4. For cohort 1 - patients receiving neoadjuvant chemotherapy are excluded, (neoadjuvant immunotherapy is permitted)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cohort 1

    Upfront resectable PDAC

    Other: Non-interventional

  • Cohort 2

    Advanced (unresectable PDAC or metastatic)

    Other: Non-interventional

Interventions

  • OtherNon-interventional

    Standard of care intervention

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What researchers measure

Primary outcomes

  1. Precision-Matched Treatment Utilization Rate

    Number of patients receiving precision-matched treatment in Ontario based on integrated correlative analysis of whole-genome sequencing (WGS), RNA sequencing (RNAseq), and patient-derived organoids (PDOs).

    Time frame: 4 years

Secondary outcomes

  1. Build a comprehensive dataset of pancreatic cancer specimens (tissue and blood) and matched patient-derived organoids (PDOs)

    Time frame: 4 years

  2. Correlate drug sensitivities in patient-derived organoids (PDOs) and molecular information

    Time frame: 4 Years

  3. Correlate immune phenotypes and molecular profiles

    Time frame: 4 Years

Other outcomes

  1. Develop an electronic medical record (EMR) platform utilizing artificial intelligence (AI) modeling

    Time frame: 4 Years

  2. Correlate serial plasma whole-genome sequencing (WGS) and tissue WGS

    Time frame: 4 Years

  3. Characterize the epigenome in established patient-derived organoids (PDOs)

    Time frame: 4 Years

  4. Assess oncolytic virus efficacy in combination with immune checkpoint inhibitors in a subset of 50 patient-derived organoids (PDOs) co-cultured with autologous peripheral blood mononuclear cells (PBMCs)

    Time frame: 4 Years

  5. Identify microbiome differences in patients at various stages of pancreatic ductal adenocarcinoma (PDAC) and their correlation with whole-genome sequencing (WGS)/RNA subtypes

    Time frame: 4 Years

  6. Document stroma subtypes in pancreatic cancer and their correlation with clinical outcomes

    Time frame: 4 Years

  7. Evaluate treatment responses in patients receiving precision-matched treatment using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Time frame: 4 Years

  8. Investigate the involvement of genetic and environmental factors in the development and progression of pancreatic cancer

    Time frame: 4 Years

  9. Assess comparability between WGS and commercial panel

    Time frame: 4 Years

  10. Explore the feasibility and efficacy of utilizing digitized whole-slide images of biopsy or resection specimens for an AI-based digital pathology prediction system

    Time frame: 4 Years

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Study locations

1 site
  • Princess Margaret Cancer Centre
    Toronto, Ontario M5G 2M9, Canada
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05927298
Lead sponsor
University Health Network, Toronto
Collaborators
Ontario Institute for Cancer Research, Ottawa Hospital Research Institute, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
Mar 6, 2023
Primary completion
Mar 6, 2027 (estimated)
Completion
Mar 6, 2027 (estimated)
Last update
Feb 20, 2026

Study contacts

Erica Tsang, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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