Trial Title:
QUALITOP - Monitoring Multidimensional Aspects of QUAlity of Life After Cancer ImmunoTherapy, an Open Smart Digital Platform for Personalized Prevention and Patient Management
NCT ID:
NCT05626764
Condition:
Solid Tumor
Hematologic Cancer
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
hematologic tumor
immunotherapy
immune checkpoint inhibitor
CAR-T cell
cancer
QoL
HR-QoL
irAEs
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
QoL & irAEs determinants
Description:
Assesment of the QoL & irAEs determinants in patients diagnosed with solid tumor and
treated in France, Netherlands, Portugal, Spain, with immunotherapy by immune checkpoint
inhibitors.
Arm group label:
Immune checkpoint inhibitors
Intervention type:
Other
Intervention name:
QoL & irAEs determinants
Description:
Assesment of the QoL & irAEs determinants in patients diagnosed with hematologic cancer
and treated in France, Netherlands, Portugal, Spain, by CAR-T cells.
Arm group label:
CAR-T cells
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
patient's 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.
Criteria for eligibility:
Study pop:
to define
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
-
- Age > 18
- Patients starting an immunotherapy treatment by immune checkpoint inhibitor or CAR-T
cells
- Patients receiving the QUALITOP informational note
- Patients receiving an immunotherapy treatment within a clinical trial could be
eligible according to the promotor of the clinical trial' indications
- Patients in clinical trial which includes a combination of therapy with one of the
drug administered in a blind manner vs placebo, can be eligible to QUALITOP provided
that (i) the treatment administered in a blind manner is not the immunotherapy and
(ii) the clinical trial allows concomitant participation of patients in
non-interventional study
- Patients treated with immunotherapy by immune checkpoint inhibitors or CAR-T cells
and recruited in the consortium clinical trials
- Patients in existing databases with a data sharing consent
Exclusion Criteria:
- Patients under 18
- Patients who received an immunotherapy treatment within 6 months before entering
QUALITOP
- Pregnant women
- Patient refusal to participate
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Medical Clinical Research Platform, Cancer Institute of the Hospices Civils de Lyon
Address:
City:
Pierre-Bénite
Zip:
69310
Country:
France
Status:
Recruiting
Contact:
Last name:
Stephane DALLE, MD
Email:
stephane.dalle@chu-lyon.fr
Facility:
Name:
Academic Medical Center Amsterdam
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
MJ KERSTEN, MD
Facility:
Name:
University Medical Center Groningen
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
GH DE BOCK
Facility:
Name:
Instituto Português de Oncologia
Address:
City:
Lisboa
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
M Gomes da Silva, MD
Facility:
Name:
Hospital Clinic de Barcelona - Consorci Institut d'Investigacions Biomediques August Pi i Sunyer
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
S Puig, MD
Start date:
January 27, 2020
Completion date:
December 2024
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626764
