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

NCT06737640 | Not Yet Recruiting

• 1 other identifier: 6881
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervical Cancer; Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of biomarkers in immunotherapy in endometrial cancer.

  Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent endometrial cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.

  12 months

• Evaluation of biomarkers in immunotherapy in cervical cancer.

  Evaluate the association between biochemical, biohumoral and molecular factors and survival outcome in patients with advanced, metastatic or recurrent cervical cancer treated with immunotherapy and chemotherapy, immunotherapy and tyrosine kinase inhibitors or immunotherapy in monotherapy.

  12 months

Secondary Outcomes (1)

• Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Use of immunotherapy within an experimental protocol.
• Patients who continued therapy at another center.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica

Rome, Lazio, 000168, Italy

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Eleonora Palluzzi, MD

  Fondazione Policlinico Agostino Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonora Palluzzi, MD

CONTACT

+390630156540; eleonora.palluzzi@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: December 16, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

IT (1)