Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
NCT ID: NCT06737640
Last Updated: 2024-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
90 participants
OBSERVATIONAL
2024-12-16
2026-12-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who continued therapy at another center.
18 Years
FEMALE
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Eleonora Palluzzi, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Agostino Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica
Rome, Lazio, Italy
Countries
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Central Contacts
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Facility Contacts
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Eleonora Palluzzi, MD
Role: primary
Other Identifiers
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6881
Identifier Type: -
Identifier Source: org_study_id