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临床试验/CTRI/2024/08/072612
CTRI/2024/08/072612招募中不适用

Registry on young women with breast cancer

Vedanta Medical Research Foundation1 个研究点 分布在 1 个国家目标入组 50,000 人开始时间: 2024年8月31日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50,000
试验地点
1
主要终点
1. To describe the profile and patterns of breast Cancer patients availing of care at the reporting hospital.

研究概览

简要总结

Breast cancer in young women is complex. Various aspects are poorly understood. There is a need for a multi-centric registry to improve our understanding of aetiology, biology, treatment patterns and outcomes in young women with breast cancer (YWBC).

 Within this registry, retrospective data collection will be conducted for YWBC diagnosed from March 2018 onwards till December 2024. Simultaneously, prospective data gathering for new patients will be facilitated through a web-based software platform. To ensure ethical standards, informed consent will be diligently obtained from new or ongoing patients, granting permission for the retrieval of pertinent data from their medical records. The decision regarding the requirement for formal informed or data release consent, in accordance with institutional policies, will be made at individual centres subsequent to approval from their respective Ethics Committee, as applicable.

 Eligible participants who consent to participation will be assigned a unique identity number to uphold confidentiality. The entry of patient data into the designated registry will exclusively after obtaining informed consent. The registry will systematically accumulate comprehensive data encompassing demographics, pertinent medical history, administered treatments, occurrences of recurrence and disease progression, details of the last follow-up, and current clinical status from the medical records of YWBC.The clinical data collected is as mentioned in the Case record form. For patients who have undergone prior treatment, relevant data available in their medical records will be meticulously captured.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • All Females who are under the age of 45 years old
  • Only Confirmed breast Cancer cases will be recruited.

排除标准

  • Male Individuals with breast cancer.
  • Female Individuals older than 45years 3.Female Individuals less than 18years.

结局指标

主要结局

1. To describe the profile and patterns of breast Cancer patients availing of care at the reporting hospital.

时间窗: 12 Weeks

次要结局

  • 1. To contribute data on breast cancer patient to develop research capacity at BALCO medical Centre.(24 Weeks)

研究者

发起方
Vedanta Medical Research Foundation
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Bhawna Sirohi

BALCO medical Center

研究点 (1)

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