Clinical trial NCT06771193: Study on Disease Characteristics and Treatment in Locally Advanced or Recurrent / Metastatic Cervical Cancer in Italy
Official title: RETRACE Study - Retrospective Observational Study Evaluating Disease Characteristics and Treatment Landscape of High-risk Locally Advanced (LA) or Recurrent / Metastatic (R/M) Cervical Cancer in Italy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Locally Advanced Cervical Cancer
Recurrent Cervical Cancer
Metastatic Cervical Cancer
Lead sponsor: MSD Italia S.r.l.
Sponsor class: INDUSTRY
First posted: 2025-01-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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 outcomes:
measure: The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: The proportion of patient with recurrence or dead after treatment and remission (%)
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: Median time from remission to recurrence
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: Number of lines of treatment
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
Secondary outcomes:
measure: The proportion of patients who undergone screening program (%)
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: HPV subtype typization, if available
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: History of HPV related lesions (CIN 2+ lesion)
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
measure: The proportion of patients with PD-L1 >1% and >50% (%)
timeFrame: Retrospective data capture from Jan 2018 to Dec 2021
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico (CRO)
state: Pordenone
city: Mestre
country: Italy
facility: UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima
state: Venezia
city: Bologna
country: Italy
facility: Oncologia Medica Policlinico Sant'Orsola Malpighi
city: Catania
country: Italy
facility: Ginecologia ed Ostetricia A.O. Cannizzaro
city: Genova
country: Italy
facility: Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
city: Modena
country: Italy
facility: Oncologia A.O.U. di Modena - Policlinico
city: Napoli
country: Italy
facility: U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
city: Napoli
country: Italy
facility: UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
city: Roma
country: Italy
facility: U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli
Study officials:
References: