Clinical trial NCT06183385: Detection of Saliva by Immunoaffinity and Mass Spectrometry
Official title: Detection of Specific Salivary Proteins by Immunoaffinity and Mass Spectrometry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Assault
Keywords: saliva
proteins
biomarkers
mass spectrometry
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-12-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Reproducibility between saliva samples
timeFrame: 3 months
measure: Intermediate fidelity between technicians on saliva samples
timeFrame: 3 months
Secondary outcomes:
measure: Reproducibility between vaginal samples soaked with saliva
timeFrame: 3 months
measure: Intermediate fidelity between technicians on vaginal samples soaked with saliva
timeFrame: 3 months
measure: Analytical Sensibility
timeFrame: 3 months
measure: Diagnostic sensibility
timeFrame: 3 months
measure: Diagnostic specificity
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: PEYRON
Study officials:
affiliation: University Hospital, Montpellier
name: Pierre-Antoine PEYRON, PI
role: STUDY_DIRECTOR
References:
citation: LOI n°2021-478 du 21 avril 2021 visant à protéger les mineurs des crimes et délits sexuels et de l'inceste. JORF n°0095 du 22 avril 2021. Texte n°4
citation: Wornes DJ, Speers SJ, Murakami JA. The evaluation and validation of Phadebas(R) paper as a presumptive screening tool for saliva on forensic exhibits. Forensic Sci Int. 2018 Jul;288:81-88. doi: 10.1016/j.forsciint.2018.03.049. Epub 2018 Apr 20.
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citation: Blanchard Muller M., Baccino E., Peyron P.A. Détection de traces salivaires dans le cadre d'agressions sexuelles : intérêt de l'utilisation d'une méthode immuno-chromatographique rapide (RSID-SalivaTest®) selon un protocole simplifié. Rev Médecine Légale 2023.
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citation: Sato H, Nakajima D, Ishikawa M, Konno R, Nakamura R, Ohara O, Kawashima Y. Evaluation of the Suitability of Dried Saliva Spots for In-Depth Proteome Analyses for Clinical Applications. J Proteome Res. 2022 May 6;21(5):1340-1348. doi: 10.1021/acs.jproteome.2c00099. Epub 2022 Apr 21.
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citation: Brown CO, Robbins BL, McKiernan HE, Danielson PB, Legg KM. Direct seminal fluid identification by protease-free high-resolution mass spectrometry. J Forensic Sci. 2021 May;66(3):1017-1023. doi: 10.1111/1556-4029.14646. Epub 2020 Dec 8.
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citation: Legg KM, Powell R, Reisdorph N, Reisdorph R, Danielson PB. Verification of protein biomarker specificity for the identification of biological stains by quadrupole time-of-flight mass spectrometry. Electrophoresis. 2017 Mar;38(6):833-845. doi: 10.1002/elps.201600352. Epub 2017 Jan 30.
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