Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy

NCT ID: NCT06771193

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-17

Study Completion Date

2025-12-31

Brief Summary

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Multicenter, Observational, Retrospective charts review. Observational study with descriptive purpose only. Retrospective data capture in consecutive patients diagnosed with CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medical records, either electronic or not), inserted in eCRF and analyzed.

Detailed Description

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This is a multicenter, observational, retrospective study. The primary aim of this trial is to describe patients and disease characteristics, as well as treatment pattern of locally advanced and recurrent/metastatic cervical cancer (R/M and LACC) in Italy, through a retrospective data capture, from January 2018 to December 2021.

Eligible cervical cancer patients will be identified by reviewing medical records and physician notes (paper or electronic).

Disease will be defined as follow:

* Locally advanced cervical cancer: a large tumour within the cervix (more than 4cm) or it has grown into the tissues around the cervix, but the cancer has not spread to other organs; usually includes stage 2B, 3 and 4A (FIGO staging)
* Recurrent cervical cancer: local tumour regrowth or development of distant metastasis discovered 6 months or more after complete regression of the treatment (26)
* Metastatic cervical cancer: cancer spreads beyond the pelvis to other parts of the body; usually defined as stage 4B (FIGO staging) Moreover, the patients' characteristics will be stratified as low risk and high risk for locally advanced cervical cancer and differences between their treatment partners will be reported.

Conditions

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Cervical Cancer Locally Advanced Cervical Cancer Recurrent Cervical Cancer Metastatic Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patient (or their legally acceptable representatives) must have signed and dated the Informed Consent \& Privacy Form (ICF)
* Age ≥18 years
* Diagnosis of a cervical cancer
* Locally advanced stage (not suitable for curative surgery) or recurrent or metastatic disease
* Any treatment received between January 2018 and December 2021 for advanced disease

Exclusion Criteria

* Patients participating in a pharmacological clinical trial for the treatment of advanced disease
* Patients who participated in a clinical trial
* Patients who were administered with Pembrolizumab, Olaparib or Levantinib or medications from these class of drugs
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MSD Italia S.r.l.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Oncologia Medica Policlinico Sant'Orsola Malpighi

Bologna, Bologna, Italy

Site Status RECRUITING

Ginecologia ed Ostetricia A.O. Cannizzaro

Catania, Catania, Italy

Site Status RECRUITING

Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino

Genova, Genova, Italy

Site Status RECRUITING

Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele

Milan, Milano, Italy

Site Status RECRUITING

Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X

Milan, Milano, Italy

Site Status RECRUITING

Oncologia A.O.U. di Modena - Policlinico

Modena, Modena, Italy

Site Status RECRUITING

U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale

Napoli, Napoli, Italy

Site Status RECRUITING

UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, Napoli, Italy

Site Status RECRUITING

IRCCS Centro di Riferimento Oncologico (CRO)

Aviano, Pordenone, Italy

Site Status RECRUITING

U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli

Roma, Roma, Italy

Site Status RECRUITING

UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima

Mestre, Venezia, Italy

Site Status NOT_YET_RECRUITING

Countries

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Italy

Central Contacts

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Stefania Lopez

Role: CONTACT

+39 03626331

Other Identifiers

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NIS102062

Identifier Type: -

Identifier Source: org_study_id

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