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临床试验/CTRI/2024/03/064737
CTRI/2024/03/064737尚未招募不适用

A prospective comparative study of preoperative and postoperative clinicopathological correlation of fibroadenoma of breast

Ramala Sandeep Reddy1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年3月31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
75
试验地点
1
主要终点
Sensitivity and Specificity of Fine needle aspiration cytology.

研究概览

简要总结

After receiving the written informed consent from study participants to participate in the study and for publication of their data, patients who presented with a history of a breast lump were clinically, and F.N.A.C. was confirmed to have Fibroadenoma of the breast. Patients will be asked about their age, residence, social status, clinical history, past history, personal history, family history and will undergo physical examination of breast, local examination of breast, inspection and palpation of breast, examination of lymph nodes, blood investigations, F.N.A.C. preoperatively and histopathology postoperatively in that order. Frequency and percentage were used to express categorical data. The Chi-square test was used to analyze the relationship between variables. Mean and Standard Deviation were used to express quantitative data. For diagnosis, histopathological findings were linked with F.N.A.C. Calculations were made for the test’s sensitivity, specificity, positive predictive value, negative predictive value, and accuracy. Statistics were considered significant for P values under 0.05.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • All patients admitted to Our Hospital with a provisional clinical diagnosis of Fibroadenoma and willing to give consent for the study Premenopausal women.

排除标准

  • Patients with clinical diagnosis of breast lump other than fibroadenoma FNAC findings other than fibroadenoma will be excluded • previously operated breast.

结局指标

主要结局

Sensitivity and Specificity of Fine needle aspiration cytology.

时间窗: 16-34 MONTHS

次要结局

  • breast, local examination of breast, inspection and palpation of breast, examination of lymph nodes, blood investigations, F.N.A.C. preoperatively and histopathology postoperatively(16-34 MONTHS)

研究者

发起方
Ramala Sandeep Reddy
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ramala Sandeep Reddy

Datta Meghe Institute Of Higher Education and Research

研究点 (1)

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