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

Merck Sharp & Dohme (MSD)

Status: Enrolling

Conditions: Metastatic Cervical Cancer; Recurrent Cervical Cancer; Locally Advanced Cervical Cancer; Cervical Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT06771193

NIS102062

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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