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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMSD Italia S.r.l.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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