Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of biomarkers in immunotherapy in endometrial cancer.
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of immunotherapy within an experimental protocol.
- •Patients who continued therapy at another center.
结局指标
主要结局
Evaluation of biomarkers in immunotherapy in endometrial cancer.
时间窗: 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.
时间窗: 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.
次要结局
- Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.(12 months)