跳至主要内容
临床试验/CTRI/2024/06/069073
CTRI/2024/06/069073已完成不适用

A prognostic risk model for the occurrence of serious adverse events in breast cancer patients on Adriamycin-based chemotherapy.

Kasturba Medical College MAHE Manipal1 个研究点 分布在 1 个国家目标入组 688 人开始时间: 2024年7月25日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
688
试验地点
1
主要终点
Occurrence of serious adverse events (SAE) in breast cancer patients on adriamycin based regimen.

研究概览

简要总结

The records of breast cancer patients undergoing Adriamycin-based therapy at the medical oncology dept will be assessed for the occurrence of serious adverse events (SAEs). The patient’s demographic and baseline data will be recorded by a pre-formed questionnaire. Predictor risk factors will be analysed for the occurrence of SAEs. All the potential risk factors for causing SAEs will be noted and considered for construction and validation of nomogram.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Women above the age of 18 years diagnosed with breast cancer and receiving Adriamycin based therapy.

排除标准

  • Women suffering from any other malignancies or on any other anti-cancer drugs.

结局指标

主要结局

Occurrence of serious adverse events (SAE) in breast cancer patients on adriamycin based regimen.

时间窗: Risk factor data will be collected & assessed following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6.

次要结局

  • To study the pattern of serious adverse events in breast cancer patients on adriamycin-based regimen.(Data on SAEs will be collected as per the predetermined data collection tool following Adriamycin-based regimen every day for 21 days at cycles 1,2,3,4,5 & 6.)

研究者

发起方
Kasturba Medical College MAHE Manipal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr R Siddhanth

Kasturba Medical College, MAHE, Manipal

研究点 (1)

Loading locations...

相似试验