Breast Cancer Clinical Trial
— G-DEFINEROfficial title:
Gender Difference in sidE eFfects of ImmuNotherapy: a Possible Clue to Optimize cancEr tReatment
NCT number | NCT04435964 |
Other study ID # | INT156-19 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 25, 2020 |
Est. completion date | February 28, 2023 |
Verified date | September 2021 |
Source | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 247 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent. - Histologically confirmed diagnosis of one of the following cancers: melanoma, lung, head and neck, urogenital, breast cancer. In addition, other solid tumors characterized by the presence of microsatellite instability (MSI-high), treated with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule. It is possible to include patients treated with Immunotherapy in a compassionate use setting. - Any disease stage. - Patients eligible for immune checkpoint inhibitors (ICI)-containing regimens: ICI single agent; Combination of ICIs; ICI-chemotherapy combination; ICI-radiotherapy combination. - Any treatment setting (neoadjuvant, adjuvant, advanced disease, maintenance). - Patient age =18 years - ECOG Performance Status of 0-2. - Adequate bone marrow, liver and renal function. - Life expectancy of at least 12 weeks. Exclusion Criteria: - Patients not eligible for ICI-containing regimens. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione IRCCS Istituto Nazionale dei Tumori | Milano |
Lead Sponsor | Collaborator |
---|---|
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Karolinska University Hospital, Oslo University Hospital, St Vincent's University Hospital, Ireland |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immune-related severe (G= 2) adverse events (irAEs) | The incidence of first severe (G= 2) irAEs of any type will be estimated in females and males | 1 year | |
Secondary | Immune-related adverse events (irAEs) | The incidence of irAEs of any type and any grade will be estimated in females and males | 1 year |
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