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NCT Number: NCT06771193

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

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.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Locally Advanced Cervical Cancer Metastatic Cervical Cancer Neoplasms Neoplasms by Site Recurrent Cervical Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oncologia Medica Policlinico Sant'Orsola Malpighi, Bologna, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).

  2. The proportion of patient with recurrence or dead after treatment and remission (%)

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    Baseline and demographic characteristics will be summarized by standard descriptive summaries using absolute frequencies and proportions (%).

  3. Median time from remission to recurrence

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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.

  4. Number of lines of treatment

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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.

  5. The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    Healthcare services for the present study include drug costs, general hospital costs (based on number of patient admissions and days of hospitalization, outpatients' visits, emergency access), specialist consultations and concomitant medications related to safety issue, radiological procedures, laboratory exams.

Secondary outcomes

  1. The proportion of patients who undergone screening program (%)

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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 (%).

  2. HPV subtype typization, if available

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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 (%).

  3. History of HPV related lesions (CIN 2+ lesion)

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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 (%).

  4. The proportion of patients with PD-L1 >1% and >50% (%)

    Time frame: Retrospective data capture from Jan 2018 to Dec 2021

    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 (%).

Study contacts

Contact information is provided by the study sponsor or research team.

Stefania Lopez

CONTACT

[email protected]

+39 03626331

Sponsors and collaborators

Lead sponsor

MSD Italia S.r.l.

Industry

Registry information

Official study 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

Acronym: RETRACE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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