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

Last updated: June 6, 2025
Sponsor: MSD Italia S.r.l.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT06771193
NIS102062
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient (or their legally acceptable representatives) must have signed and dated theInformed Consent & Privacy Form (ICF)

  • Age ≥18 years

  • Diagnosis of a cervical cancer

  • Locally advanced stage (not suitable for curative surgery) or recurrent ormetastatic disease

  • Any treatment received between January 2018 and December 2021 for advanced disease

Exclusion

Exclusion Criteria:

  • Patients participating in a pharmacological clinical trial for the treatment ofadvanced disease

  • Patients who participated in a clinical trial

  • Patients who were administered with Pembrolizumab, Olaparib or Levantinib ormedications from these class of drugs

Study Design

Total Participants: 200
Study Start date:
December 17, 2024
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • IRCCS Centro di Riferimento Oncologico (CRO)

    Aviano, Pordenone 33081
    Italy

    Site Not Available

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

    Mestre, Venezia
    Italy

    Site Not Available

  • Oncologia Medica Policlinico Sant'Orsola Malpighi

    Bologna,
    Italy

    Active - Recruiting

  • Ginecologia ed Ostetricia A.O. Cannizzaro

    Catania, 95126
    Italy

    Active - Recruiting

  • Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Active - Recruiting

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

    Milano, 30159
    Italy

    Active - Recruiting

  • Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele

    Milano, 20132
    Italy

    Active - Recruiting

  • Oncologia A.O.U. di Modena - Policlinico

    Modena, 41124
    Italy

    Active - Recruiting

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

    Napoli, 80131
    Italy

    Active - Recruiting

  • UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Napoli, 80138
    Italy

    Site Not Available

  • U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli

    Roma, 00168
    Italy

    Active - Recruiting

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