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临床试验/CTRI/2025/08/092485
CTRI/2025/08/092485尚未招募不适用

A STUDY OF CLINICAL SIGNIFIANCE OF SERUM PROSTATE SPECIFIC ANTIGEN IN BREAST CANCER PATIENTS- A ONE YEAR OBSERVATIONAL STUDY.

Dr Gaddam Rishitha1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年8月20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
24
试验地点
1
主要终点
To compare serum Prostrate specific antigen values in breast cancer patients and healthy females

研究概览

简要总结

Breast cancer is the most common malignancy in women worldwide and one of the leading causes of cancer death . Triple negative breast cancer is defined by the lack of estrogen and progesterone receptors as well as an absence of HER2 (human epidermal growth factor receptor 2) amplification. Because of the lack of specific targeted therapy, 30–40% of patients with early-stage TNBC develop metastatic disease and succumb to the cancer, despite receiving standard multi-agent adjuvant chemotherapy  .Both molecular and immunohistochemical analyses demonstrate that a subset of TNBC expresses androgen resistance [ AR ] . AR dependency has also been suggested in a subset of ER-negative, AR-positive breast cancers. Recently, numerous preclinical studies have validated the use of AR modulation in limiting cell proliferation, growth on soft agar, and tumor initiation in vivo and there are ongoing clinical trials evaluating the efficacy of AR antagonists in ER- negative breast cancer for bicalutamide, enzalutamide.

In this study, we investigate whether sPSA might reflect tumor biology, including AR signaling. Using blood samples from both healthy controls and breast cancer patients, individuals were enrolled regardless of age clinicopathological factor or treatment history. sPSA was evaluated by chemiluminescent enzyme immunoassay (CLEIA) method at various timepoints for each case. Then correlations between sPSA and clinicopathological factors were analyzed .

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Female

入选标准

  • Female patients confirmed to have invasive breast cancer and those willing to give consent for the same .

排除标准

  • Patients who denied the procedure .
  • Patients who present with a lump in the breast whose tissue diagnosis revealed they were benign .
  • Patients with uterine pathologies Immunocompromised patients.

结局指标

主要结局

To compare serum Prostrate specific antigen values in breast cancer patients and healthy females

时间窗: Preoperative - with in 8 weeks from surgery

次要结局

  • To know the significance of serum Prostrate specific antigen in breast cancer patients .(Preoperative , within 8 weeks from surgery)

研究者

发起方
Dr Gaddam Rishitha
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Gaddam Rishitha

KLE University Jawaharlal Nehru Medical College

研究点 (1)

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