Detection of Specific Salivary Proteins by Immunoaffinity and Mass Spectrometry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Reproducibility between saliva samples
研究概览
简要总结
The identification of saliva in genital area during a criminal investigation can be a critical component in the prosecution of a sexual assault in France, as non-consensual oral-genital intercourses have been considered as crimes since 2021.The development of highly specific methods for saliva detection is therefore crucial as the commonly employed screening methods lack specificity. Protein mass spectrometry has proven to be a sensitive and specific method but is particularly time consuming. A faster and more sensitive hybrid approach using automated immunoaffinity mass spectrometry (IP-LC-MS/MS) has been recently developed and has been found to be particularly performant for the detection of a seminal fluid protein (semenogelin), allowing a high-throughput seminal fluid identification in semen samples. Like semenogelin, specific salivary proteins such as histatin type 1, cystatin D or proline-rich proteins (PRPs) could be detected using this promising approach, which has never been tested on saliva samples. In collaboration with the Clinical Proteomics Platform and the Department of Reproductive Medicine of the University Hospital of Montpellier, we aim to develop a protocol for the detection of specific saliva proteins by IP-LC-MS/MS in sexual assault-type samples.
详细描述
Each participant will be contacted by a phone call the day before the visit, to present for a presentation of the study.The day of the visit, two types of samples will be collected :
- Saliva samples: on healthy volunteers in the Department of Legal Medicine (2 samples of 1.5 - 2 mL are collected for each volunteer).
- Vaginal samples : on women consulting in the Department of Reproductive Medicine (2 dry swabs on each patient). 2 groups, One group with vaginal secretion fluid samples only, and one group with vaginal secretion fluid + sperm samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Saliva Samples
- •Men and women aged 18 or more
- •Vaginal samples :
- •Women aged 18 or more
- •No unprotected vaginal sexual intercourse during the 10 days prior to the visit (group 1)
- •Unprotected vaginal sexual intercourse with ejaculation in the 24 hours prior to the visit (group 2)
排除标准
- •Saliva Samples :
- •Active pathology of the saliva glands (infection, tumor)
- •Unprotected oral-genital sexual intercourse in the 24 hours prior to the visit
- •Failure to obtain written informed consent after a reflection period
- •Pregnant or breast feeding women
- •Adult protected by law or under guardianship or curatorship
- •No affiliation to the French Social Security System or no benefit from such a system
- •Vaginal Samples :
- •Oral-genital sexual intercourse (cunnilingus) in the 24 hours prior to the visit
- •Failure to obtain written informed consent after a reflection period
- •Pregnant or Breastfeeding women
- •Adult protected by law or under guardianship or curatorship
- •No affiliation to the French Social Security System or no benefit from such a system
结局指标
主要结局
Reproducibility between saliva samples
时间窗: 3 months
Intra-assessor agreement on saliva samples, which involves testing the first sample and retesting the second sample The study's primary endpoint will be to measure the reliability of the protocol, consisting of reproducibility or intra-assessor agreement,for the detection of specific salivary proteins (histatin type 1, PRPs, cystatin D) using the IP-LC-MS/MS method on adult saliva samples. Intra-assessor agreement (test/retest) will be measured by their means +/- standard deviation. Several analyses (between 3 or 4) on the same sample will be carried out to determine whether the results are identical
Intermediate fidelity between technicians on saliva samples
时间窗: 3 months
Inter-assessor agreement(Cohen's kappa coefficient) on saliva samples, which involves testing several samples by at least 2 different technicians The study's primary endpoint will be to measure the reliability of the protocol, consisting of intermediate fidelity or inter-assessor agreement (Cohen's kappa coefficient) for the detection of specific salivary proteins (histatin type 1, PRPs, cystatin D) using the IP-LC-MS/MS method on adult saliva samples. The kappa coefficient gives a score ranging from 0 to 1. If the coders totally agree, κ = 1. If they totally disagree (or agree due solely to chance), κ ≤ 0.
次要结局
- Analytical Sensibility(3 months)
- Reproducibility between vaginal samples soaked with saliva(3 months)
- Intermediate fidelity between technicians on vaginal samples soaked with saliva(3 months)
- Diagnostic sensibility(3 months)
- Diagnostic specificity(3 months)