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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:
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| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Lopez | Contact | +39 03626331 | info.studiclinici@opisresearch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologia Medica Policlinico Sant'Orsola Malpighi | Recruiting | Bologna | Bologna | Italy | ||
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| 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 |
| Ginecologia ed Ostetricia A.O. Cannizzaro |
| Recruiting |
| Catania |
| Catania |
| 95126 |
| Italy |
| Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | Genova | 16132 | Italy |
| Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele | Recruiting | Milan | Milano | 20132 | Italy |
| Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X | Recruiting | Milan | Milano | 30159 | Italy |
| Oncologia A.O.U. di Modena - Policlinico | Recruiting | Modena | Modena | 41124 | Italy |
| U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale | Recruiting | Naples | Napoli | 80131 | Italy |
| UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli | Recruiting | Naples | Napoli | 80138 | Italy |
| IRCCS Centro di Riferimento Oncologico (CRO) | Recruiting | Aviano | Pordenone | 33081 | Italy |
| U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli | Recruiting | Roma | Roma | 00168 | Italy |
| UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima | Not yet recruiting | Mestre | Venezia | Italy |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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