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

Petra C. Vinke*, Marc Combalia, Geertruida H. De Bock, Clémence Leyrat, Anne Mea Spanjaart, Stephane Dalle, Maria Gomes Da Silva, Aurore Fouda Essongue, Aurélie Rabier, Myriam Pannard, Mohammad S. Jalali, Amal Elgammal, Mike Papazoglou, Mohand Said Hacid, Catherine Rioufol, Marie José Kersten, Martijn G.H. Van Oijen, Erick Suazo-Zepeda, Ananya Malhotra, Emmanuel CoqueryAmélie Anota, Marie Preau, Mathieu Fauvernier, Elsa Coz, Susana Puig*, Delphine Maucort-Boulch

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

2 Citations (Scopus)
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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.

Original languageEnglish
Article numbere069090
Number of pages15
JournalBMJ Open
Issue number4
Publication statusPublished - 27-Apr-2023


  • Adverse events
  • Epidemiology


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