Ignite Creation Date:
2024-05-06 @ 6:19 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05626764
Status:
RECRUITING
Last Update Posted:
2022-11-25
First Post:
2022-10-25
Brief Title:
QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy an Open Smart Digital Platform for Personalized Prevention and Patient Management
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy an Open Smart Digital Platform for Personalized Prevention and Patient Management - QUALITOP -
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
An increasing number of cancer patients are eligible to receive immunotherapy Efficacy and tolerance have been demonstrated in multicentre randomized clinical trials with positive results However real-life experience differs from clinical trial results especially regarding the management of potential adverse events HR-QoL Health Related Quality of Life is one of the components of QoL Quality of Life in its broad acceptation and is certainly the only one usually collected in trials while little is known about QoL in cancer patients treated in the real-world QUALITOP partners intend to bring together all relevant longitudinal information present in large heterogeneous data big data to estimate patient QoL and find surrogate markers of QoL and its evolution Within the QUALITOP consortium 5 countries will collect prospective clinical and QoL data and also retrospective clinical data and share it This project will enable collecting managing sharing modelling processing and exploiting big data on QoL Furthermore beyond the description of QoL analytical tools including causal inference methods and machine learning are needed to understand the determinants of QoL and their complex relationships with irAEs immune related Adverse Events in a big-data context where standard statistical techniques would be limited Artificial intelligence and causal models may be applied and developed to empower the patient prevent adverse medical conditions and promote QoL The created knowledge will enable proposing guidelines for promoting better QoL
QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events IR-AEs such as toxicities depending on the patients profile in a real-world context
The richness of QUALITOP is in the diversity of the experts who will collaborate in it Clinicians involved in the care thus the health status of the patients will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption Epidemiologists data scientists including bioinformaticians and biostatisticians and economists will extract information from the data and develop simulation models to produce knowledge The project will take place in close relation with patient associations that will interact with experts to design the analyses interpret their results and proceed to their dissemination
The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life
Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management with data on clinical information health-related QoL HR-QoL IR-AEs drug consumption lifestyle and administrative data
Accelerate knowledge directed to different stakeholders patients relatives clinicians pharmacists health authorities and the general public for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools artificial intelligence and causal models
Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs Sustainable Development Goals for 4P medicine Predictive Preventive Personalized Participative in immunotherapy for cancer patients
QUALITOP aims at identifying the determinants of health status regarding immunotherapy-related adverse events IR-AEs such as toxicities depending on the patients profile in a real-world context
The richness of QUALITOP is in the diversity of the experts who will collaborate in it Clinicians involved in the care thus the health status of the patients will collaborate with psychologists and sociologists to understand and integrate complementary dimensions of QoL related to immunotherapy Experts in pharmacovigilance and pharmacists will investigate the IR-AEs and their associations with patient behaviour and non-drug consumption Epidemiologists data scientists including bioinformaticians and biostatisticians and economists will extract information from the data and develop simulation models to produce knowledge The project will take place in close relation with patient associations that will interact with experts to design the analyses interpret their results and proceed to their dissemination
The main objective is to collect data of patients receiving immunotherapy in order to describe its impact in their quality of life
Create the first real-life cohort of cancer patients treated with immunotherapy within a context of multidimensional management with data on clinical information health-related QoL HR-QoL IR-AEs drug consumption lifestyle and administrative data
Accelerate knowledge directed to different stakeholders patients relatives clinicians pharmacists health authorities and the general public for a better understanding of the determinants of QoL and its optimization after immunotherapy through the development of innovative analytic tools artificial intelligence and causal models
Produce policies and recommendations to improve patients QoL and participate in the implementation of the SDGs Sustainable Development Goals for 4P medicine Predictive Preventive Personalized Participative in immunotherapy for cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None