跳至主要内容
临床试验/NCT06260358
NCT06260358招募中不适用

Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Efficacy of a contextual structured report

研究概览

简要总结

This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.

Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥18 years old;
  • Overt biopsy-proven diagnosis of cervical cancer, at any stage;
  • Signed written informed consent to personal data treatment for research purposes

排除标准

  • Age <18 years old;
  • Uncertain diagnosis of cervical cancer;
  • MRI scan not according the standard acquisition protocol (ESUR guidelines);
  • Patients candidate to non-standard treatments;
  • Refusal to sign the written informed consent to personal data treatment for research purposes

结局指标

主要结局

Efficacy of a contextual structured report

时间窗: 1 year

Primary endpoint of the study is to assess referring physicians' (gynecologists and radiation oncologists) overall satisfaction rate with structured reports for staging MRI of patients with cervical cancer, in terms of overall response rate ≥4 at the first 5 items (i.e., an overall score ≥20)

次要结局

  • Satisfaction rate with narrative and structured report(1 year)
  • Comparison Single items response rate, on both narrative and structured reports(1 year)
  • Differences in the single 6-to-12 items response rate between structured and narrative reports.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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