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
Brief Summary

Multicenter, Observational, Retrospective charts review. Observational study withdescriptive purpose only. Retrospective data capture in consecutive patients diagnosedwith CC who attended the Oncologic Clinics from Jan 2018 to Dec 2021 (using medicalrecords, 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.

Recruiting
Cervical Cancer
Locally Advanced Cervical Cancer
Recurrent Cervical Cancer
Metastatic Cervical Cancer
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

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Italy
Locations

IRCCS Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, Italy

UOC Oncologia Medica Ospedale Dell'Angelo - Mestre Azienda USL3 Serenissima
Mestre, Venezia, Italy

Oncologia Medica Policlinico Sant'Orsola Malpighi
Bologna, Italy

Ginecologia ed Ostetricia A.O. Cannizzaro
Catania, Italy

Oncologia Medica 1 IRCCS Ospedale Policlinico San Martino
Genova, Italy

Unità di Ginecologia Oncologica Medica IRCCS Ospedale San Raffaele
Milano, Italy

Unità Ostetricia, Ginecologia e Ginecologia Oncologica medica Humanitas San Pio X
Milano, Italy

Oncologia A.O.U. di Modena - Policlinico
Modena, Italy

U.O.S. Trattamenti Innovativi dell'utero Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale
Napoli, Italy

UOC Oncologia Medica ed Ematologia Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, Italy

U.O.C. Ginecologia Oncologica Policlinico Agostino Gemelli
Roma, Italy

Contacts

Stefania Lopez
+39 03626331
info.studiclinici@opisresearch.com

Not Provided

MSD Italia S.r.l.
NCT Number
MeSH Terms
Uterine Cervical Neoplasms
Recurrence