NCT04217109已完成不适用
KDOG1 :Transcutaneous Breast Cancer Diagnosis by Canine Odorology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 13
- 主要终点
- Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
研究概览
简要总结
Patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the Breast Imaging (BI) Report and Data System of the American College of Radiology (RADS) classification detected at mammography and/or breast ultrasound examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as BI-RADS® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ;
- •Benefit from the national social security ;
- •Signature of the informed consent of the study ;
- •There is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study.
排除标准
- •Patient with bilateral breast lesions classified as BI-RADS® category 4 or 5;
- •Patient with breast implant(s);
- •Patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study;
- •Patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma;
- •Patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion;
- •Patient with a breast skin ulceration;
- •Patient under insulin (risk of sudation that may impair compress sample);
- •Concomitant antibiotics or corticoids taken one week before inclusion in the study;
- •Patient with a current viral infection (fever);
- •Persons under guardianship or deprived of liberty;
- •Impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.
结局指标
主要结局
Evaluate the sensitivity and specificity of canine odorology in women with breast lesion
时间窗: 26 months
The sensitivity and specificity of canine odorology in women with undeterminate breast lesion classified American College of Radiology (ACR) 4 or 5 (typically malignant) will be compared to the anatomopathological results of breast percutaneous sampling (biopsy)
次要结局
- Patient compliance during the study(26 months)
- Sensitivity (markings on patients affected) and specificity (no-markings on patients not affected)(38 months)
- Positive predictive value (PPV) and negative predictive value (NPV) of canine odorology(38 months)
- Comparison between canine odorology and mammography(38 months)
- Performance of each dog(26 months)
- Performance of canine odorology if the test is based on 2 dogs(24 months)
- Variability between dogs(26 months)
- Patient's satisfaction(26 months)
研究者
研究点 (13)
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