Clinical trial NCT06737640: Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
Official title: Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Cancer
Endometrial Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced, metastatic or recurrent endometrial cancer and advanced, metastatic or recurrent cervical cancer undergoing treatment with immunotherapy in combination with chemotherapy or tyrosine kinase inhibitors or with immunotherapy as monotherapy.

Brief 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).


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.

Primary outcomes:
measure: Evaluation of biomarkers in immunotherapy in endometrial cancer.
timeFrame: 12 months
measure: Evaluation of biomarkers in immunotherapy in cervical cancer.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Agostino Gemelli, IRCCS
name: Eleonora Palluzzi, MD
role: PRINCIPAL_INVESTIGATOR
References: