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临床试验/CTRI/2024/12/078269
CTRI/2024/12/078269尚未招募不适用

Development of predictive nomogram for assessing pathological complete response after neo-adjuvant chemotherapy in treatment naive non-metastatic breast cancer patients - An ambispective study

All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
380
试验地点
1
主要终点
To develop a predictive nomogram to predict pathological complete response in treatment naïve non metastatic breast cancer patients receiving neoadjuvant

研究概览

简要总结

Breast cancer is the most common malignancy in women and leading cause of cancer related deaths amongst them. There is a difference in the clinical and demographic presentation of breast cancer patients in India compared to the West. Asians are younger to Western women with breast cancer at time of diagnosis. Prevalence of Triple negative breast cancer is more in Indian than Western women. Hence, the predictors of desired response to chemotherapy are also expected to differ. No study has been carried out in the Indian subcontinent to identify the predictors of complete response to chemotherapy in breast cancer patients. There is a striking difference in the clinical and demographic profile of breast cancer patients from India and the west. There is no published study in English literature from Indian sub continent on this subject. The few available studies from the west have used differing parameters as marker for response assessment making a head on comparison difficult. Hence, we wish to study the factors influencing response to Neoadjuvant chemotherapy and develop a predictive nomogram for the same. This may help in individualized patient treatment planning in the future.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Treatment naïve non-metastatic breast cancer patients receiving/received neoadjuvant chemotherapy
  • For prospective group: patients consenting to participate in the study.

排除标准

  • Breast cancer patients with previous history of surgery or radiotherapy to chest and axilla.
  • Metastatic breast cancer at presentation.
  • Patients not consenting to participate in the study.
  • Patients having incomplete records.

结局指标

主要结局

To develop a predictive nomogram to predict pathological complete response in treatment naïve non metastatic breast cancer patients receiving neoadjuvant

时间窗: From enrollment to final histopathology (06 months)

chemotherapy

时间窗: From enrollment to final histopathology (06 months)

次要结局

  • To validate the predictive nomogram developed to identify the patients having a(likelihood of achieving pathological complete response in treatment naïve non)
  • To study the factors predicting pathological complete response in treatment naïve(non metastatic breast cancer patients receiving neoadjuvant chemotherapy)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Suhani

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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