Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

Pancreas Cancer Clinical Trial

— ProsperPanc  

Official title:

Province of Ontario Strategy for Personalized Management of Pancreatic Cancer Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927298
• Other study ID #: OZUHN-011
• Status: Recruiting
• Start date: March 6, 2023
• Est. completion date: March 6, 2027

Study information

• Verified date: June 2023
• Source: University Health Network, Toronto
• Contact: Anna Dodd
• Phone: 647-539-6498
• Email: anna.dodd[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 6, 2027
• Est. primary completion date: March 6, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Other:
• Non-interventional
Standard of care intervention

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	Lawson Health Research Institute, Ontario Institute for Cancer Research, Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AI-Based Electronic Medical Record (EMR) Platform Development	Development of an electronic medical record (EMR) platform utilizing artificial intelligence (AI) modeling for enhanced data analysis and decision-making.	4 Years
Other	Correlation Between Serial Plasma WGS and Tissue WGS	Correlation between serial plasma whole-genome sequencing (WGS) and tissue WGS for monitoring treatment response and identifying potential biomarkers.	4 Years
Other	Epigenomic Characterization of PDOs	Characterization of the epigenome in established patient-derived organoids (PDOs) to understand epigenetic alterations and their impact on treatment response.	4 Years
Other	Evaluation of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors	Assessment of 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).	4 Years
Other	Microbiome Differences and Correlation with WGS/RNA Subtypes	Identification of microbiome differences in patients at various stages of pancreatic ductal adenocarcinoma (PDAC) and their correlation with whole-genome sequencing (WGS)/RNA subtypes.	4 Years
Other	Stroma Subtypes Documentation and Correlation with Outcomes	Documentation of different stroma subtypes in pancreatic cancer and their correlation with clinical outcomes to understand their impact on disease progression and patient prognosis.	4 Years
Other	Response Assessment in Precision-Matched Treatment	Evaluation of treatment responses in patients receiving precision-matched treatment using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	4 Years
Other	Genetic and Environmental Factors in Pancreatic Cancer	Investigation of the involvement of genetic and environmental factors in the development and progression of pancreatic cancer.	4 Years
Primary	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	Pancreatic Cancer Specimen and PDO Dataset	Comprehensive dataset of pancreatic cancer specimens (tissue and blood) and matched patient-derived organoids (PDOs)	4 years
Secondary	Drug Sensitivity Correlation with Molecular Information	Correlation between drug sensitivities in patient-derived organoids (PDOs) and molecular information from high-throughput drug screening.	4 Years
Secondary	Correlation of Immune Phenotypes and Molecular Profiles	Relationship between immune phenotypes (assessed using image mass cytometry) and molecular profiles, such as basal-like/classical subtypes.	4 Years