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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced pancreatic ductal adenocarcinoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Profiling | Genetic | Whole Genome Sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| The feasibility of prospectively identifying subgroups of patients with advanced PDAC who have distinct genomic characteristics for better treatment selection while undergoing 1st-line chemotherapy using next generation sequencing. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate achieved by m-FOLFIRINOX | 5 years | |
| Disease control rate achieved by nab-paclitaxel | 5 years | |
| Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to m-FOLFIRINOX |
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Inclusion Criteria:
Exclusion Criteria:
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Locally advanced or metastatic pancreatic ductal adenocarcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer J. Knox, M.D. | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Kingston | Ontario | K7L2V7 | Canada | ||
| Princess Margaret Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31481506 | Derived | Karasinska JM, Topham JT, Kalloger SE, Jang GH, Denroche RE, Culibrk L, Williamson LM, Wong HL, Lee MKC, O'Kane GM, Moore RA, Mungall AJ, Moore MJ, Warren C, Metcalfe A, Notta F, Knox JJ, Gallinger S, Laskin J, Marra MA, Jones SJM, Renouf DJ, Schaeffer DF. Altered Gene Expression along the Glycolysis-Cholesterol Synthesis Axis Is Associated with Outcome in Pancreatic Cancer. Clin Cancer Res. 2020 Jan 1;26(1):135-146. doi: 10.1158/1078-0432.CCR-19-1543. Epub 2019 Sep 3. | |
| 29288237 |
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| ID | Term |
|---|---|
| D021441 | Carcinoma, Pancreatic Ductal |
| ID | Term |
|---|---|
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| 5 years |
| Duration of response defined as the interval between the first date of complete response or partial response and the earliest date of disease progression or death due to any cause to nab-paclitaxel. | 5 years |
| Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with m-FOLFIRINOX. | 5 years |
| Progression free survival defined as the interval between the date of registration and the earliest date of disease progression or death due to any cause of patients treated with nab-paclitaxel. | 5 years |
| Overall survival defined as the interval between the date of registration and the date of death of patients treated with m-FOLFIRINOX | 5 years |
| Overall survival defined as the interval between the date of registration and the date of death of patients treated with nab-paclitaxel. | 5 years |
| Correlation between tumor genomic characteristics and m-FOLFIRINOX response using next generation sequencing. | 5 years |
| Correlation between tumor genomic characteristics and nab-paclitaxel response using the next generation sequencing. | 5 years |
| Percentage of patients with germline BRCA, PALB2 and ATM mutations who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibition. | 5 years |
| Percentage of patients with somatic DSBR deficiency who might benefit from a personalized treatment strategy such as combination of cisplatin and a PARP inhibitor. | 5 years |
| Percentage of patients who might benefit from immunotherapy (patients with smoking genomic signatures, patients with a hypermutated phenotype, patients with mismatch repair deficiency and patients with tumor neo-antigen expression). | 5 years |
| Percentage of patients with rare but targetable somatic mutations. | 5 years |
| Difference in disease control rate between patients with tumor smoking signature and those without. | 5 years |
| Difference in overall survival between patients with tumor smoking signature and those without. | 5 years |
| Correlation with tumor molecular characteristics and toxicities to treatment using next generation sequencing. | 5 years |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | H2X 3E4 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A3J1 | Canada |
| Derived |
| Aung KL, Fischer SE, Denroche RE, Jang GH, Dodd A, Creighton S, Southwood B, Liang SB, Chadwick D, Zhang A, O'Kane GM, Albaba H, Moura S, Grant RC, Miller JK, Mbabaali F, Pasternack D, Lungu IM, Bartlett JMS, Ghai S, Lemire M, Holter S, Connor AA, Moffitt RA, Yeh JJ, Timms L, Krzyzanowski PM, Dhani N, Hedley D, Notta F, Wilson JM, Moore MJ, Gallinger S, Knox JJ. Genomics-Driven Precision Medicine for Advanced Pancreatic Cancer: Early Results from the COMPASS Trial. Clin Cancer Res. 2018 Mar 15;24(6):1344-1354. doi: 10.1158/1078-0432.CCR-17-2994. Epub 2017 Dec 29. |
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D010190 | Pancreatic Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |