An observational study in Solid Tumor and Hematologic Cancer, sponsored by Hospices Civils de Lyon. Status unknown at 5 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-25.
Sponsored by Hospices Civils de Lyon · Observational
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.
1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 200 across 331 observational studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,854 studies on the registry; 441 are open to participants now.
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Exclusion Criteria:
Any immunotherapy by immune checkpoint inhibitor molecule in combination or monotherapy, associated or no with any other cancer treatment such as chemotherapy, targeted therapy, radiotherapy, etc.
Other: QoL & irAEs determinants
Transplantation of recombined autologous immune T-cells
Other: QoL & irAEs determinants
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.
Assesment of the QoL \& irAEs determinants in patients diagnosed with hematologic cancer and treated in France, Netherlands, Portugal, Spain, by CAR-T cells.
Assesment of the QoL& irAEs determinants in patients diagnosed with solid or hematologic cancer and treated in France, Netherlands, Portugal, Spain, with immunotherapy by immune checkpoint inhibitors or CAR-T cells.
Descriptive analysis of QoL determinants (which are there ? what are their impacts ? etc) based on collected data from the beginning of the treatment to 2 years.
Time frame: Clinical data will be collected during 18 months starting from treatment initiation, or until the last patient reaches the 18 months follow-up. Clinical and biological changes occurring during the treatment will be assessed and compared to baseline. QoL
Plan to share: Undecided
Started Jan 2020 (actual). Primary completion is estimated for Dec 2023, 47 months after the start.
Of 165 non-industry observational studies under Hematologic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 234. This study's planned 47 months is below that.
Counting every sponsor, half of 185 studies reached it within 72 months; a quarter within 32 and three quarters within 234.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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