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Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer

NCT06737640 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-12-17

No results posted yet for this study

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).

Conditions

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Eleonora Palluzzi, MD · Fondazione Policlinico Agostino Gemelli, IRCCS

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06737640 on ClinicalTrials.gov