Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

NCT05927298 | Active Not Recruiting

• 1 other identifier: OZUHN-011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreas Cancer

Outcome Measures

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).

  4 years

Secondary Outcomes (3)

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

  4 years

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

  4 Years

• Correlate immune phenotypes and molecular profiles

  4 Years

Other Outcomes (10)

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

  4 Years

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

  4 Years

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

  4 Years

Study Arms (2)

Cohort 1

Upfront resectable PDAC

Other: Non-interventional

Cohort 2

Advanced (unresectable PDAC or metastatic)

Other: Non-interventional

Interventions

Non-interventional OTHER

Standard of care intervention

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients must have either upfront resectable PDAC or advanced (unresectable or metastatic) PDAC (borderline PDAC and those planned for neoadjuvant chemotherapy excluded)
• 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.
• 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.
• For patients with advanced PDAC (cohort 2), all stages are eligible including locally advanced unresectable, first-line metastatic, second-line (or beyond) metastatic.
• 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.
• Patients must have a life expectancy of ≥ 6 months
• ECOG 0-1
• Patient must be suitable for systemic therapy
• Patients should have organ function deemed sufficiently adequate to receive systemic therapy

You may not qualify if:

• Certain histologies are excluded: colloid, high grade neuroendocrine;
• 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.
• 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.
• For cohort 1 - patients receiving neoadjuvant chemotherapy are excluded, (neoadjuvant immunotherapy is permitted)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator
• University Health Network, Toronto: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tumour tissue will undergo WGS/RNAseq. Germline blood samples will be used as reference

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Erica Tsang, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: July 3, 2023
• Study Start: March 6, 2023
• Primary Completion (Estimated): March 6, 2027
• Study Completion (Estimated): March 6, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)