跳至主要内容
临床试验/CTRI/2026/02/104406
CTRI/2026/02/104406尚未招募不适用

CORRELATION OF CLINICAL EXAMINATION, RADIOLOGICAL IMAGING AND HISTOPATHOLOGY IN THE DIAGNOSIS OF BREAST LUMP

YUVRAJSINH MAHIDA1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
The study aims to assess the correlation between clinical, radiological, and histopathological findings in palpable breast lumps.

研究概览

简要总结

Breast lumps are a common clinical presentation with a wide spectrum ranging from benign conditions to malignant lesions. Accurate and timely diagnosis is essential to ensure early detection of malignancy while avoiding unnecessary interventions for benign diseases. The triple assessment approach—clinical examination, radiological imaging, and histopathological evaluation—is considered the gold standard for breast lump evaluation.

This hospital-based prospective observational study will be conducted at a tertiary care centre to assess the clinical profile of patients presenting with palpable breast lumps and to correlate radiological findings with histopathological diagnosis. Female patients above 15 years with palpable breast lumps will be included. Clinical examination, ultrasonography with BI-RADS classification, and pathological evaluation using FNAC and/or biopsy will be performed.

The study aims to evaluate the diagnostic accuracy of radiological imaging in differentiating benign and malignant breast lesions and to determine the sensitivity, specificity, positive predictive value, and negative predictive value of radiological assessment. The findings are expected to improve diagnostic accuracy, facilitate early detection of breast cancer, and contribute locally relevant data to guide clinical practice and diagnostic protocols, especially in resource-limited settings

研究设计

研究类型
Observational

入排标准

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

入选标准

  • •MORE THAN 15 YEARS OF FEMALE WITH LUMP IN BREAST.

排除标准

  • •Patients with breast trauma or infection (e.g., abscesses).
  • •Pregnant or lactating women.

结局指标

主要结局

The study aims to assess the correlation between clinical, radiological, and histopathological findings in palpable breast lumps.

时间窗: over a period of twenty-four months, from June 2025 to June 2027.

It will evaluate the diagnostic accuracy of different modalities to identify cost-effective and reliable diagnostic pathways.

时间窗: over a period of twenty-four months, from June 2025 to June 2027.

The findings may help in early detection of malignancy, reduce diagnostic delays, and improve patient outcomes.

时间窗: over a period of twenty-four months, from June 2025 to June 2027.

The study will also provide locally relevant data to guide screening protocols and clinical practice.

时间窗: over a period of twenty-four months, from June 2025 to June 2027.

次要结局

  • The findings may help in early detection of malignancy, reduce diagnostic delays, and improve patient outcomes.

研究者

发起方
YUVRAJSINH MAHIDA
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

YUVRAJSINH MAHIDA

DATTA MEGHE MEDICAL COLLEGE, NAGPUR

研究点 (1)

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