Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study - Hospices Civils de Lyon
Article Dans Une Revue BMJ Open Année : 2023

Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study

Petra Vinke
Marc Combalia
  • Fonction : Auteur
Geertruida de Bock
  • Fonction : Auteur
Clémence Leyrat
  • Fonction : Auteur
Anne Mea Spanjaart
  • Fonction : Auteur
Stéphane Dalle
Maria Gomes da Silva
  • Fonction : Auteur
Aurore Fouda Essongue
  • Fonction : Auteur
Aurélie Rabier
  • Fonction : Auteur
Myriam Pannard
  • Fonction : Auteur
Mohammad Jalali
Amal Elgammal
  • Fonction : Auteur
Mike Papazoglou
  • Fonction : Auteur
Mohand-Said Hacid
  • Fonction : Auteur
Catherine Rioufol
  • Fonction : Auteur
Marie-José Kersten
  • Fonction : Auteur
Martijn Gh van Oijen
  • Fonction : Auteur
Erick Suazo-Zepeda
  • Fonction : Auteur
Ananya Malhotra
  • Fonction : Auteur
Emmanuel Coquery
  • Fonction : Auteur
Amélie Anota
  • Fonction : Auteur
Marie Preau
  • Fonction : Auteur
Elsa Coz
  • Fonction : Auteur
Susana Puig
  • Fonction : Auteur

Résumé

Introduction Immunotherapies, such as immune checkpoint inhibitors and chimeric antigen receptor T-cell therapy, have significantly improved the clinical outcomes of various malignancies. However, they also cause immune-related adverse events (irAEs) that can be challenging to predict, prevent and treat. Although they likely interact with health-related quality of life (HRQoL), most existing evidence on this topic has come from clinical trials with eligibility criteria that may not accurately reflect real-world settings. The QUALITOP project will study HRQoL in relation to irAEs and its determinants in a real-world study of patients treated with immunotherapy. Methods and analysis This international, observational, multicentre study takes place in France, the Netherlands, Portugal and Spain. We aim to include about 1800 adult patients with cancer treated with immunotherapy in a specifically recruited prospective cohort, and to additionally obtain data from historical real-world databases (ie, databiobanks) and medical administrative registries (ie, national cancer registries) in which relevant data regarding other adult patients with cancer treated with immunotherapy has already been stored. In the prospective cohort, clinical health status, HRQoL and psychosocial well-being will be monitored until 18 months after treatment initiation through questionnaires (at baseline and 3, 6, 12 and 18 months thereafter), and by data extraction from electronic patient files. Using advanced statistical methods, including causal inference methods, artificial intelligence algorithms and simulation modelling, we will use data from the QUALITOP cohort to improve the understanding of the complex relationships among treatment regimens, patient characteristics, irAEs and HRQoL. Ethics and dissemination All aspects of the QUALITOP project will be conducted in accordance with the Declaration of Helsinki and with ethical approval from a suitable local ethics committee, and all patients will provide signed informed consent. In addition to standard dissemination efforts in the scientific literature, the data and outcomes will contribute to a smart digital platform and medical data lake. These will (1) help increase knowledge about the impact of immunotherapy, (2) facilitate improved interactions between patients, clinicians and the general population and (3) contribute to personalised medicine. Trial registration number NCT05626764 .
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Dates et versions

hal-04150720 , version 1 (04-09-2024)

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Petra Vinke, Marc Combalia, Geertruida de Bock, Clémence Leyrat, Anne Mea Spanjaart, et al.. Monitoring multidimensional aspects of quality of life after cancer immunotherapy: protocol for the international multicentre, observational QUALITOP cohort study. BMJ Open, 2023, 13 (4), pp.e069090. ⟨10.1136/bmjopen-2022-069090⟩. ⟨hal-04150720⟩
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