$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

2023-03-06

2027-03-06

2027-03-06

200

Study Overview

Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

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

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.

  • Pancreas Cancer
  • OTHER: Non-interventional
  • OZUHN-011

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-01-25  

N/A  

2024-10-09  

2023-06-21  

N/A  

2024-10-15  

2023-07-03  

N/A  

2024-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/ArmIntervention/Treatment
: Cohort 1

Upfront resectable PDAC

OTHER: Non-interventional

  • Standard of care intervention
: Cohort 2

Advanced (unresectable PDAC or metastatic)

OTHER: Non-interventional

  • Standard of care intervention
Primary Outcome MeasuresMeasure DescriptionTime Frame
Precision-Matched Treatment Utilization RateNumber 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 Outcome MeasuresMeasure DescriptionTime Frame
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 information4 Years
Correlate immune phenotypes and molecular profiles4 Years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Anna Dodd

Phone Number: 647-539-6498

Email: anna.dodd@uhn.ca

Study Contact Backup

Name: Stephanie Ramotar

Phone Number:

Email: stephanie.Ramotar@uhn.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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:
    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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate