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

RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Stefania Lopez; Phone Number: +39 03626331; Email: info.studiclinici@opisresearch.com

Study Locations

• Italy
  • Bologna, Italy
    • Recruiting
    • Oncologia Medica Policlinico Sant'Orsola Malpighi
  • Catania, Italy, 95126
    • Recruiting
    • Ginecologia ed Ostetricia A.O. Cannizzaro
  • Genova, Italy, 16132
    • Recruiting
    • Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino
  • Milano, Italy, 20132
    • Recruiting
    • Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
  • Milano, Italy, 30159
    • Recruiting
    • Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
  • Modena, Italy, 41124
    • Recruiting
    • Oncologia A.O.U. di Modena - Policlinico
  • Napoli, Italy, 80131
    • Recruiting
    • U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
  • Napoli, Italy, 80138
    • Recruiting
    • UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
  • Roma, Italy, 00168
    • Recruiting
    • U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Recruiting
      • Irccs Centro Di Riferimento Oncologico (CRO)
  • Venezia
    • Mestre, Venezia, Italy
      • Not yet recruiting
      • UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who attend the Oncologic Clinics authorized to participate in the study, with a record of diagnosed cervical cancer, treated between January 2018 and December 2021, will be eligible for inclusion in this study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)	Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).	Retrospective data capture from Jan 2018 to Dec 2021
The proportion of patient with recurrence or dead after treatment and remission (%)	Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).	Retrospective data capture from Jan 2018 to Dec 2021
Median time from remission to recurrence	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.	Retrospective data capture from Jan 2018 to Dec 2021
Number of lines of treatment	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.	Retrospective data capture from Jan 2018 to Dec 2021
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC	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.	Retrospective data capture from Jan 2018 to Dec 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients who undergone screening program (%)	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 (%).	Retrospective data capture from Jan 2018 to Dec 2021
HPV subtype typization, if available	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 (%).	Retrospective data capture from Jan 2018 to Dec 2021
History of HPV related lesions (CIN 2+ lesion)	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 (%).	Retrospective data capture from Jan 2018 to Dec 2021
The proportion of patients with PD-L1 >1% and >50% (%)	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 (%).	Retrospective data capture from Jan 2018 to Dec 2021

Collaborators and Investigators

• Sponsor: MSD Italia S.r.l.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Recurrence; Uterine Cervical Neoplasms
• Other Study ID Numbers: NIS102062

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No