Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment (G-DEFINER)

Study identification

• EU PAS number:
  EUPAS31282
• Study ID:
  44938
• Official title and acronym:
  Gender Difference in sidE eFfects of ImmuNotherapy: a possible clue to optimize cancEr tReatment (G-DEFINER)
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  Italy

  Norway

  Sweden
• Study description:
  The study is a multicenter prospective observational study aimed at investigating sex and gender differences in the immune-related adverse events (irAEs) development in relation to clinical factors and genetic, immunological and hormonal profiles in patients with melanoma, lung, head and neck, urogenital, breast cancer treated with immunocheckpoint inhibitors (ICI). Exploring the irAEs occurrence in a real world context will be more easily translated in a ready-to-use personalized approach to irAEs timely diagnosis and treatment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Fondazione IRCCS Istituto Nazionale dei Tumori

Karolinska University Hospital

Oslo University Hospital

Dublin City University - St Vincent’s University Hospital Dublin, Ireland, Karolinska University Hospital Stockholm, Sweden, Oslo University Hospital Oslo, Norway

Study timelines

Date when funding contract was signed

Actual:19/02/2019

Study start date

Planned:15/06/2020

Actual:25/06/2020

Date of final study report

Planned:28/02/2023

Sources of funding

EU institutional research programme

More details on funding

Horizon 2020 GENDERNET PLUS ERANET

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable