Checking blood and molecular markers in womb and cervical cancer immunotherapy
Looks at blood and molecular markers in womb or cervical cancer patients given immunotherapy.
Plain-language title generated from the registry record
Registry title: Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia OncologicaRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT06737640
- Record updated
- 17 December 2024
- Original description
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.Read full original descriptionShow less
Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients
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).
Inclusion: 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: Use of immunotherapy within an experimental protocol; Patients who continued therapy at another center.