Cervical Cancer, Endometrial Cancer
Conditions
Brief summary
Background: Immunotherapy has changed the therapeutic approach for gynecologic gynecological malignancies such us endometrial and cervical cancer. Despite literature data support the strong effect of immunotherapy in these cancers, a share of patients do not respond to immunotherapy. Furthermore the extremely variable immune-related spectrum of toxicity in terms of events and timing makes it necessary to identify predictive factors for the development of these side effects. Hyphotesis: To evaluate the presence of biochemical, bioumoral and or molecular predictive factors in patients affected by endometrial and cervical cancer treated with immunotherapy plus chemotherapy, immunotherapy plus tyrosine kinase inhibitors (TKI) or immunotherapy alone. Methodology: We will retrospectively collect data about patients affected by advanced, recurrent or metastatic endometrial cancer (EC) and recurrent cervical cancer (CC) treated with immunotherapy. We will investigate whether there is a statistically significant difference in the efficacy of immunotherapy according to biochemical, biohumoral and or molecular factors and survival outcomes. Moreover, we will evaluate whether there is a correlation between biochemical, biohumoral and or molecular factors and immune-related adverse events (irAE).
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females aged ≥ 18 years at the time of inclusion in the study. * Patients diagnosed with advanced, metastatic or recurrent endometrial and cervical cancer treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS. * Patients with histological confirmation of endometrial and cervical cancer, according to the histotypes suitable for immunotherapy. * Patients previously treated under Nominal Use and/or Expanded Access Program (EAP) programs can be enrolled in the study. * Patients who have received at least 1 dose of immunotherapy after starting treatment. * Signature of the informed consent or declaration in lieu of the consent form where applicable
Exclusion criteria
* Use of immunotherapy within an experimental protocol. * Patients who continued therapy at another center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of biomarkers in immunotherapy in endometrial cancer. | 12 months | Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent endometrial cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy. |
| Evaluation of biomarkers in immunotherapy in cervical cancer. | 12 months | Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent cervical cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer. | 12 months | Evaluate the association between biochemical, biohumoral and possibly molecular factors and the onset of immune-related adverse events during and after the end of immunotherapy treatment. |
Countries
Italy
Contacts
Primary ContactEleonora Palluzzi, MD
Outcome results
None listed