Cancer Clinical Trial
— PanGenOfficial title:
Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis
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.
Status | Recruiting |
Enrollment | 190 |
Est. completion date | December 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | BC Cancer - Vancouver | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency | American Society of Clinical Oncology, BC Cancer Foundation, Pancreas Centre BC, Terry Fox Research Institute |
Canada,
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* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Engraftment rate of patient-derived xenografts | 5 years | ||
Other | Success rate of establishing patient-derived organoids | 5 years | ||
Other | DNA damage repair pathways | Percentage of patients with somatic or germline alterations in DNA damage repair pathways | 5 years | |
Other | Hypermutated phenotype | Percentage of patients with a hypermutated phenotype | 5 years | |
Other | Mismatch repair deficiency | Percentage of patients with mismatch repair deficiency | 5 years | |
Other | Neo-antigen load | Percentage of patients with a high tumour neo-antigen load | 5 years | |
Other | Targetable mutations | Percentage of patients with rare but targetable mutations | 5 years | |
Primary | 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 | Response Rate | Response rate defined as the percentage of patients with complete (CR) or partial response (PR) per RECIST 1.1 | Up to an average of 1 year | |
Secondary | Disease Control Rate | Disease control rate defined as the percentage of patients who experience CR, PR, or stable disease by RECIST 1.1 | Up to an average of 1 year | |
Secondary | Duration of Response | Duration of response defined as the interval between the first date of CR or PR and the earliest date of disease progression or death due to any cause | Up to an average of 1 year | |
Secondary | Progression-Free Survival | Progression-free survival (PFS) defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause | Up to an average of 1 year | |
Secondary | Overall Survival | Overall survival (OS) defined as the interval between the date of registration and the date of death. | Up to an average of 1 year |
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