免费获得国外相关药品，最快 1 个工作日回馈药物信息
PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors (PATAKESS)
PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)).
PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor.
| Condition or disease |
|---|
| Exocrine Pancreatic Cancer |
Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors.
However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available.
In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010.
| Study Type : | Observational |
| Estimated Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Official Title: | PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors |
| Estimated Study Start Date : | April 2020 |
| Estimated Primary Completion Date : | April 2023 |
| Estimated Study Completion Date : | April 2023 |
- Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [ Time Frame: Up to 36 months ]Clinical characteristics of patients are consistent with tumor response at each treatment line and disease stage at diagnosis ; Biological characteristics will describe molecular alterations of the tumor by sequencing techniques like Next Generation Sequencing (NGS)
- Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [ Time Frame: Up to 36 months ]Comparative characterization of the different stroma by immunological detection
- Comparison of different tumor stroma : from surgery specimen of primitive tumor with preoperative chemotherapy, versus from surgery specimen of primitive tumor without preoperative chemotherapy, versus from biopsies done before chemotherapy [ Time Frame: Up to 36 months ]Comparative characterization of the different stroma by NGS
- Comparison of tumor stroma from primitive tumor versus from metastases [ Time Frame: Up to 36 months ]Comparative characterization of the different stroma by immunological detection
- Comparison of tumor stroma from primitive tumor versus from metastases [ Time Frame: Up to 36 months ]Comparative characterization of the different stroma by NGS
Biospecimen Retention: Samples Without DNA
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Male or female patient 18 age or older
- Patient operated on for exocrine pancreatic adenocarcinoma at Centre Léon Bérard since 01/01/2010.
- Histological diagnosis of exocrine pancreatic adenocarcinoma confirmed with surgery specimen.
Exclusion Criteria:
- Not applicable
| Contact: Philippe CASSIER | 04 26 55 68 33 | philippe.cassier@lyon.unicancer.fr |
| Principal Investigator: | Philippe CASSIER | Centre Leon Berard |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 20, 2019 | ||||
| First Posted Date | July 9, 2019 | ||||
| Last Update Posted Date | February 5, 2020 | ||||
| Estimated Study Start Date | April 2020 | ||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Determination of the correlation between clinical characterizations and biological characterizations of patients suffering from exocrine pancreatic cancer [ Time Frame: Up to 36 months ] Clinical characteristics of patients are consistent with tumor response at each treatment line and disease stage at diagnosis ; Biological characteristics will describe molecular alterations of the tumor by sequencing techniques like Next Generation Sequencing (NGS)
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors | ||||
| Official Title | PATAKESS Protocol : Clinical and Biological Analysis of Exocrine Pancreatic Tumors | ||||
| Brief Summary |
PATAKESS is a monocentric non interventional cohort study (prospective (alive patients) and retrospective (dead patients with biological material from surgery and/or biopsies already collected)). PATAKESS consists of clinical and biological analyses of exocrine pancreatic tumors. Data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. The main objective is to determine correlation between biological and clinical characterizations of patients suffering from exocrine pancreatic tumor. |
||||
| Detailed Description |
Pancreatic adenocarcinoma cancer is an aggressive cancer which represents 95% of pancreatic cancer. Pancreatic adenocarcinoma cancer is one of the deadliest cancers (5th cause of death per cancer) ; it has a very poor prognosis: 5-year survival (regardless of all stades at diagnosis). Pancreatic adenocarcinoma cancer is characterized by early metastasis. Therefore, development of efficient systemic therapeutics is one of the keys to improving prognosis. Newly developed immune check-point inhibitors seem to have limited efficacy in pancreatic adenocarcinoma except for MSI-H (Microsatellite instability-high) or dMMR (mismatch repair deficient)/MSI-H tumors. However, recent data suggest that immune surveillance could control metastatic dissemination of pancreatic adenocarcinoma cancer. Several studies showed strong interactions between pancreatic tumor cells and tumor stroma in metastatic dissemination and in resistance to conventional therapeutics. Many data about pancreatic primitive tumors from murine animals models are available ; however few data on tumor stroma and its interactions with tumor cells of metastasis from adenocarcinoma pancreas are available. Few data on correlation between molecular alterations types (mutations, deletions, amplifications) in pancreatic adenocarcinoma cells and tumor stroma characteristics (primitive and metastatic stroma (cells composition, immune infiltration)) are also available. In PATAKESS study, clinical and biological data are derived from tumor samples taken for routine health care purposes in patients managed at Centre Léon Bérard (Lyon-France) since January 2010. |
||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
Exocrine pancreatic tumor samples from initial diagnosis biopsy and/or from surgery specimen of primitive tumor and/or from metastases.
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients operated on for exocrin pancreatic adenocarcinoma since January 1st, 2010. | ||||
| Condition | Exocrine Pancreatic Cancer | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment |
100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | April 2023 | ||||
| Estimated Primary Completion Date | April 2023 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
|
||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04011982 | ||||
| Other Study ID Numbers | ET19-033 (PATAKESS) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Centre Leon Berard | ||||
| Study Sponsor | Centre Leon Berard | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Centre Leon Berard | ||||
| Verification Date | June 2019 | ||||
