Feasibility Study on the Possibility of Isolation of Volatile Organic Compounds (VOCs) Related to the Olfactory Signature of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To ascertain the possibilities to isolate the breast cancer olfactive signature
研究概览
简要总结
To ascertain the possibilities to isolate the breast cancer olfactive signature
详细描述
Patient recruitment during the first surgery consultation in Curie Institute.
Odor sampling (non-invasive) with an odor-sensing polymer (Sorbstar® polymer developed especially for the trace level analysis), on:
- The hands, before and after surgical excision of the tumor (friction of the hands)
- The diseased breast, before and after surgical excision of the tumor (via a compress positioned on the breast for 1 night)
- The tumor, during the surgical procedure (odor collection over a tumor sample).
Each patient will be her own witness, before and after surgical excision, in an attempt to isolate the chemical signature tracks of breast cancer. The samples after surgery will be made after healing and before implementation of a treatment (chemotherapy and / or radiotherapy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient received in surgery consultation for an invasive non metastatic breast cancer treated by breast-conserving surgery with axillary or sentinel node dissection
- •Of-Age female patient (over 18 years old)
- •Life expectancy > to 1 year at the inclusion
- •ECOG performance status: 0 or 1 or 2
- •Patient benefiting from the social security
- •Signature informed consent of the study
排除标准
- •Neoplasia in progress or neoplasia history of cancer other than breast to be treated.
- •Wound presence on breasts
- •Male subjects
- •Pregnant or lactating women
- •Specified metastatic breast cancer
- •Concomitant medication taken one month before the surgical act (antibiotics, corticoids, anti-diabetics)
- •Persons under guardianship or deprived of liberty
- •Impossibility to submit to the medical monitoring expected by the study for geographical, social or psychological reasons.
研究组 & 干预措施
Sorbstar®
Odour sampling : rub hands with Sorbstars® before and post-surgery
干预措施: Sorbstar® (Diagnostic Test)
Dog Detection
Odour sampling :sleep over a night with a compress on the affected breast before and after surgery
干预措施: Dog Detection (Diagnostic Test)
结局指标
主要结局
To ascertain the possibilities to isolate the breast cancer olfactive signature
时间窗: 18 months
Isolation of volatile Organic Compounds to breast cancer by a sensitive technique with an odor-sensing polymer (Sorbstar®) on hands. Friction of the hands according to the protocol before and after surgical excision of the tumor. Sorbstar® analyses will be performed with a thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.
次要结局
- Ascertain breast cancer detection by the dogs of Curie Institut(18 months)
- Ascertain breast cancer olfactive signature from the tumor (Isolation of volatile Organic Compounds to tumor breast samples by a sensitive technique with an odor-sensing polymer (Sorbstar®)(18 months)