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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).
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of biomarkers in immunotherapy in endometrial cancer. | 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. | 12 months |
| Evaluation of biomarkers in immunotherapy in cervical cancer. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer. | 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with advanced, metastatic or recurrent endometrial cancer and advanced, metastatic or recurrent cervical cancer undergoing treatment with immunotherapy in combination with chemotherapy or tyrosine kinase inhibitors or with immunotherapy as monotherapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleonora Palluzzi, MD | Contact | +390630156540 | eleonora.palluzzi@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Eleonora Palluzzi, MD | Fondazione Policlinico Agostino Gemelli, IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica | Rome | Lazio | 000168 | Italy |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |