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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The proportion of patients receiving each different treatment pattern of LA, recurrent, and metastatic CC (%)
时间窗: 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 (%).
The proportion of patient with recurrence or dead after treatment and remission (%)
时间窗: 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 (%).
Median time from remission to recurrence
时间窗: 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.
Number of lines of treatment
时间窗: 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.
The costs in terms of resources utilization associated to the different treatment patterns of LA, recurrent and metastatic CC
时间窗: 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.
次要结局
- History of HPV related lesions (CIN 2+ lesion)(Retrospective data capture from Jan 2018 to Dec 2021)
- The proportion of patients with PD-L1 >1% and >50% (%)(Retrospective data capture from Jan 2018 to Dec 2021)
- The proportion of patients who undergone screening program (%)(Retrospective data capture from Jan 2018 to Dec 2021)
- HPV subtype typization, if available(Retrospective data capture from Jan 2018 to Dec 2021)