Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Endometrial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients
Overview
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).
Primary outcome measures
- Evaluation of biomarkers in immunotherapy in endometrial cancer. [Time frame: 12 months]
- Evaluation of biomarkers in immunotherapy in cervical cancer. [Time frame: 12 months]
Secondary outcome measures (1)
- Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer. [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica — Rome
Identifiers
NCT: NCT06737640 · 6881