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.
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
200
Oncologia Medica Policlinico Sant'Orsola Malpighi
Bologna, Bologna, Italy
RECRUITINGGinecologia ed Ostetricia A.O. Cannizzaro
Catania, Catania, Italy
RECRUITINGOncologia Medica 1 IRCCS Ospedale Policlinico San Martino
Genova, Genova, Italy
RECRUITINGUnità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
Milan, Milano, Italy
RECRUITINGUnità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
Milan, Milano, Italy
RECRUITINGOncologia A.O.U. di Modena - Policlinico
Modena, Modena, Italy
RECRUITINGU.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Napoli, Napoli, Italy
RECRUITINGUOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, Napoli, Italy
RECRUITINGIRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, Italy
RECRUITINGU.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli
Roma, Roma, Italy
RECRUITING...and 1 more locations
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 (%).
Time frame: 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 (%).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
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 (%).
Time frame: 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 (%).
Time frame: 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 (%).
Time frame: 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 (%).
Time frame: Retrospective data capture from Jan 2018 to Dec 2021
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