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临床试验/CTRI/2024/03/063796
CTRI/2024/03/063796尚未招募2 期

Role of Shear wave elastography in assessment of response to neoadjuvant chemotherapy (NACT) in breast cancer patients.

Tata Memorial Hospital, Parel1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
To assess role of shear wave elastography in predicting the responders vs non

研究概览

简要总结

**Breast cancer is one the most common cancer occurring in the world and in India. Breast cancer treatment includes chemotherapy, surgery and radiotherapy. In some stages of breast cancer, size of tumor is large without metastasis to other sites of body. In this stage of tumor, chemotherapy (NACT- Neo Adjuvant Chemo Therapy) is given before the surgery to decrease size of tumor so that less extensive surgery can be performed.****In this proposed study, we are trying to study response to this chemotherapy (NACT) using elastography.**Elastography measures hardness (stiffness) of tissue.Elastography is performed along with sonography of breast using the same machine where additional measurements (of stiffness of tissue) are taken along with routine sonographic evaluation.Our hypothesis here is, as the patient is on chemotherapy, the hardness of the tissue should decrease and so should thevalues onelastography and if this decrease in elastography values correlates with final outcome of patient on histopathology report.

For the study the patient will have to undergo additional ultrasonographic evaluation (intervention) post 2 cycles of chemotherapy, the values of which which will be compared to baseline ultrasonography parameters (Performed as standard of care in TMH). We will finally evaluate if elastography values can predict responders vs non responders to NACT.

The patient will not be charged for this intervention. If a certain patient does not come or denies this additional investigation or denies to be a part of the study at any given time, that patient will not be included in the study and standard of care will not be affected.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • HPR proven Operable breast cancer patients, planned for treatment (NACT + Surgery) in TMH
  • Age more than 18 years
  • Oligometastatic disease where treatment intent is curative.

排除标准

  • Metastatic disease
  • Cystic lesion– elastography is not useful
  • DCIS with no measurable mass on USG
  • Inflammatory breast cancer
  • Pregnancy
  • Patients whose pre chemotherapy images are incomplete
  • Treatment defaulters (Patients who refuse, delay or discontinue treatment at any time point during the study) and those who receive any treatment outside TMH.

结局指标

主要结局

To assess role of shear wave elastography in predicting the responders vs non

时间窗: 2 years

responders to NACT in breast cancer patients.

时间窗: 2 years

次要结局

  • To predict pathological complete response in responders using elastography values.Â
  • Subset analysis of different types and grades of breast cancers for response to NACT.(2 years)

研究者

发起方
Tata Memorial Hospital, Parel
申办方类型
Other [organisation]
责任方
Principal Investigator
主要研究者

Dr Purvi Haria

Tata Memorial Hospital, Parel

研究点 (1)

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