Cervical CancerImmuno-GynNCT06737640
Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
An observational study of Cervical Cancer and Endometrial Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 16 Dec 2024to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Use of immunotherapy within an experimental protocol.
- Patients who continued therapy at another center.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia Oncologica
Rome, Lazio, 000168
Eleonora Palluzzi, MD, eleonorapalluzzi@gmail.com
Eleonora Palluzzi, MD
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (1)
Evaluation of immuno-related adverse events (irAEs) in gynecologic cancer.
Evaluate the association between biochemical, biohumoral and possibly molecular factors and the onset of immune-related adverse events during and after the end of immunotherapy treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start16 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleonora Palluzzi, MD, Principal investigator, Fondazione Policlinico Agostino Gemelli, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737640
- Sponsor's protocol ID
- 6881
- Acronym
- Immuno-Gyn
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No