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

Recruiting

• Conditions: Cervical Cancer; Locally Advanced Cervical Cancer; Recurrent Cervical Cancer; Metastatic Cervical Cancer

• Registration Number: NCT06771193
• Lead Sponsor: MSD Italia S.r.l.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-12-17
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)	Retrospective data capture from Jan 2018 to Dec 2021	Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
The proportion of patient with recurrence or dead after treatment and remission (%)	Retrospective data capture from Jan 2018 to Dec 2021	Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
Median time from remission to recurrence	Retrospective data capture from Jan 2018 to Dec 2021	The study aim is to describe the time from curative intervention to recurrence (for patients who had a curative surgery).; Time to recurrence will be calculated and represented using Kaplan-Meier curves and summarized using median with 95% confidence interval.
Number of lines of treatment	Retrospective data capture from Jan 2018 to Dec 2021	The aim of this analysis is to describe patients' treatment patterns in LA or R/M Cervical Cancer considering the high heterogeneity of treatment options in clinical setting and the lack of real-world data in Italy.
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC	Retrospective data capture from Jan 2018 to Dec 2021	Healthcare services for the present study include drug costs, general hospital costs (based on number of patient admissions and days of hospitalization, outpatients' visits, emergency access), specialist consultations and concomitant medications related to safety issue, radiological procedures, laboratory exams.

Secondary Outcome Measures

Name	Time	Method
History of HPV related lesions (CIN 2+ lesion)	Retrospective data capture from Jan 2018 to Dec 2021	Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
The proportion of patients with PD-L1 >1% and >50% (%)	Retrospective data capture from Jan 2018 to Dec 2021	To describe the expression profile of PD-L1 (if available in archive pathology reports).; Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
The proportion of patients who undergone screening program (%)	Retrospective data capture from Jan 2018 to Dec 2021	Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).
HPV subtype typization, if available	Retrospective data capture from Jan 2018 to Dec 2021	Baseline characteristics such as adherence to a screening program, HPV subtype, and PD-L1 expression will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).

Trial Locations

Locations (11)

Ginecologia ed Ostetricia A.O. Cannizzaro; 🇮🇹 Catania, Italy

Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy

Oncologia Medica Policlinico Sant'Orsola Malpighi; 🇮🇹 Bologna, Italy

IRCCS Centro di Riferimento Oncologico (CRO); 🇮🇹 Aviano, Pordenone, Italy

UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima; 🇮🇹 Mestre, Venezia, Italy

Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X; 🇮🇹 Milano, Italy

Oncologia A.O.U. di Modena - Policlinico; 🇮🇹 Modena, Italy

U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale; 🇮🇹 Napoli, Italy

UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli; 🇮🇹 Napoli, Italy

U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli; 🇮🇹 Roma, Italy