Cervical CancerLocally Advanced Cervical CancerRecurrent Cervical CancerMetastatic Cervical Cancer
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
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
Trial sites (11)
Facility
City
Region
Status
Oncologia Medica Policlinico Sant'Orsola Malpighi
Bologna
Bologna
Recruiting
Ginecologia ed Ostetricia A.O. Cannizzaro
Catania
Catania
Recruiting
Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino
Genova
Genova
Recruiting
Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
Milan
Milano
Recruiting
Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
Milan
Milano
Recruiting
Oncologia A.O.U. di Modena - Policlinico
Modena
Modena
Recruiting
U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Naples
Napoli
Recruiting
UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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