About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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 (%).
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 (%).
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.
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.
Secondary outcomes
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 (%).
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 (%).
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 (%).
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 (%).
Sponsors and contacts
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