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Gender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment

NCT04435964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 247

Last updated 2023-03-24

No results posted yet for this study

Summary

The study aim is to investigate the differences between sex and gender in the immune-related adverse events (irAEs) development associated with immune checkpoint inhibitors (ICI) treatment. The study will be a multicenter prospective observational study focusing on biological differences between females and males, possibly affecting discrepant irAEs incidence.

Conditions

Interventions

DRUG

Immunotherapy

Patients treated as per clinical prescription with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule, either as single agent or in combination with chemotherapy and/or radiotherapy

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • St Vincent's University Hospital, Ireland

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Rosalba Miceli, PhD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04435964 on ClinicalTrials.gov