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临床试验/CTRI/2022/01/039262
CTRI/2022/01/039262尚未招募不适用

Clinical outcomes and quality of life in patients with locally advanced vulvovaginal cancers: ambispective registration study.

Tata Memorial Centre1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
To report patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy): RFS, DFS

研究概览

简要总结

The vaginal cancers are responsible for 2% of gynecological cancer while vulvar cancers account for 4 % of gynecological cancers. HPV 16 and 33 are most prevalent in vaginal cancers and account for more than half of cases HPV related vaginal cancer. However, adeqaute information is not there. Similarly, structured QOL data is not available for India.  Therefore, in the proposed study we will like to systematically evaluate the patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy). The therapeutic research in vulvo-vaginal cancers has been relatively slow and such structured registration databases can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30 and VU-34) in rare cancers. We hope that we will get help in identifying thrust areas for future research including prospective interventional trials through this study.

研究设计

研究类型
Observational

入排标准

年龄范围
16.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • Patients diagnosed with vulvo-vaginal cancer.
  • Patients treated with Radiation+/- chemotherapy +/- surgery from January 1, 2019- December 31, 2023.

排除标准

  • Patients with Metastatic disease at the presentation.
  • Incomplete information on the EMR.

结局指标

主要结局

To report patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy): RFS, DFS

时间窗: 3 Years

次要结局

  • To report outcomes as a function of p16, AKT, PDL-1 expression.(5 Years)
  • To report on acute and late effect of treatment outcomes using CTCAE.(5 Years)
  • To report on longitudinal QOL using EORTC QLQ C-30 and VU-34 (English, Hindi, Marathi as applicable)(4,8,12,16,20,24,30,36,42,48, 54,60 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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