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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.

Key facts

Who runs it
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Where
Rome, ItalySee the site
Trial code
Registry title
Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer
Status
Not yet recruiting
People taking part
90 people, planned
Started
16 Dec 2024
Expected to end
31 Dec 2026
Type of study
Observational
Record updated
17 December 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with advanced, spreading or returning endometrial or cervical cancer who were treated with immunotherapy at the Gemelli hospital.

Age
18 years or older
Sex
Women only
Disease stage
Advanced, metastatic or recurrent endometrial or cervical cancer, confirmed by tissue examination, of a type treated with immunotherapy.
Earlier treatment
Must have received at least 1 dose of immunotherapy. Patients treated under Nominal Use or Expanded Access Programs can join.

Main reasons for not taking part

  • Immunotherapy given within an experimental protocol
  • Continued treatment at another center

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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 take part

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

Where in Italy

  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, UOC Ginecologia OncologicaRome, ItalyContact: Eleonora Palluzzi, MDNo longer taking part

About the trial

What the trial wants to find out

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

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Biochimical, Bioumoral and Molecular Features as Predicitive Factors of Response or Toxicities During Immunotherapy Treatment of Uterine Cancer Patients
Plain-language title
Checking blood and molecular markers in womb and cervical cancer immunotherapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
17 December 2024