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

NCT06771193 | Recruiting

• 1 other identifier: NIS102062
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 11

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• The proportion of patients who undergone screening program (%)

  Retrospective data capture from Jan 2018 to Dec 2021

• HPV subtype typization, if available

  Retrospective data capture from Jan 2018 to Dec 2021

• History of HPV related lesions (CIN 2+ lesion)

  Retrospective data capture from Jan 2018 to Dec 2021

• The proportion of patients with PD-L1 >1% and >50% (%)

  Retrospective data capture from Jan 2018 to Dec 2021

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MSD Italia S.r.l.: lead

Study Sites (11)

Oncologia Medica Policlinico Sant'Orsola Malpighi

Bologna, Bologna, Italy

RECRUITING

Ginecologia ed Ostetricia A.O. Cannizzaro

Catania, Catania, 95126, Italy

RECRUITING

Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino

Genova, Genova, 16132, Italy

RECRUITING

Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

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

Milan, Milano, 30159, Italy

RECRUITING

Oncologia A.O.U. di Modena - Policlinico

Modena, Modena, 41124, Italy

RECRUITING

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

Napoli, Napoli, 80131, Italy

RECRUITING

UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, Napoli, 80138, Italy

RECRUITING

IRCCS Centro di Riferimento Oncologico (CRO)

Aviano, Pordenone, 33081, Italy

RECRUITING

U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli

Roma, Roma, 00168, Italy

RECRUITING

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

Mestre, Venezia, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Stefania Lopez

CONTACT

+39 03626331; info.studiclinici@opisresearch.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: December 17, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-03

Locations

IT (11)