Detection of Saliva by Immunoaffinity and Mass Spectrometry
NCT ID: NCT06183385
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
35 participants
INTERVENTIONAL
2024-01-15
2024-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Saliva
Collection of two saliva samples (approx. 1.5 to 2 mL each) by passive drooling in healthy volunteers
These samples will be centrifuged and the supernatant collected.
Saliva collection
Collection of 2 samples of 1.5 to 2mL of saliva by passive salivation in healthy volunteers
IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry
sample preparation and analysis :
* Impregnation of the tips (absorbent cotton) of sterile dry swabs and vaginal swabs with controlled quantities of saliva.
* Immunocapture of salivary proteins of interest (histatin type 1, cystatin D, PRPs) by protein A affinity purification
* LC-MS/MS analysis of eluted purified peptides (Multiple Reaction Monitoring mode)
Dilutions will be made from 10 to 10 (1/10, 1/100, 1/1000...), then after reaching a detectability threshold, specified by a second more precise analysis (e.g. if no signal at 1/1000, analysis at 1/500 then 1/250 etc.). Analytical sensitivity will be tested on three samples of each type (salivary, vaginal, vaginal + semen) to ensure reproducibility of results.
Operators, unaware of the presence of saliva in the samples, will then carry out saliva-specific protein detection analysis using the IP-LC-MS/MS method.
Vaginal secretions
In order to be as close as possible to real life, two vaginal swabs (introduced through the vaginal orifice over a length of 2 to 3 cm) will be taken with a sterile dry swab during the gynecological examination (prior to endovaginal ultrasound or any other endovaginal procedure) of patients included in the Reproductive Medicine Service.
Vaginal secretion collection
Collection of vaginal secretions with 2 dry swabs in women
IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry
sample preparation and analysis :
* Impregnation of the tips (absorbent cotton) of sterile dry swabs and vaginal swabs with controlled quantities of saliva.
* Immunocapture of salivary proteins of interest (histatin type 1, cystatin D, PRPs) by protein A affinity purification
* LC-MS/MS analysis of eluted purified peptides (Multiple Reaction Monitoring mode)
Dilutions will be made from 10 to 10 (1/10, 1/100, 1/1000...), then after reaching a detectability threshold, specified by a second more precise analysis (e.g. if no signal at 1/1000, analysis at 1/500 then 1/250 etc.). Analytical sensitivity will be tested on three samples of each type (salivary, vaginal, vaginal + semen) to ensure reproducibility of results.
Operators, unaware of the presence of saliva in the samples, will then carry out saliva-specific protein detection analysis using the IP-LC-MS/MS method.
Interventions
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Saliva collection
Collection of 2 samples of 1.5 to 2mL of saliva by passive salivation in healthy volunteers
Vaginal secretion collection
Collection of vaginal secretions with 2 dry swabs in women
IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry
sample preparation and analysis :
* Impregnation of the tips (absorbent cotton) of sterile dry swabs and vaginal swabs with controlled quantities of saliva.
* Immunocapture of salivary proteins of interest (histatin type 1, cystatin D, PRPs) by protein A affinity purification
* LC-MS/MS analysis of eluted purified peptides (Multiple Reaction Monitoring mode)
Dilutions will be made from 10 to 10 (1/10, 1/100, 1/1000...), then after reaching a detectability threshold, specified by a second more precise analysis (e.g. if no signal at 1/1000, analysis at 1/500 then 1/250 etc.). Analytical sensitivity will be tested on three samples of each type (salivary, vaginal, vaginal + semen) to ensure reproducibility of results.
Operators, unaware of the presence of saliva in the samples, will then carry out saliva-specific protein detection analysis using the IP-LC-MS/MS method.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Pierre-Antoine PEYRON, PI
Role: STUDY_DIRECTOR
University Hospital, Montpellier
Locations
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PEYRON
Montpellier, , France
Countries
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Central Contacts
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References
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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
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.
Vandenberg N, van Oorschot RA. The use of Polilight in the detection of seminal fluid, saliva, and bloodstains and comparison with conventional chemical-based screening tests. J Forensic Sci. 2006 Mar;51(2):361-70. doi: 10.1111/j.1556-4029.2006.00065.x.
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.
Davidovics R, Saw YL, Brown CO, Prinz M, McKiernan HE, Danielson PB, Legg KM. High-throughput seminal fluid identification by automated immunoaffinity mass spectrometry. J Forensic Sci. 2022 May;67(3):1184-1190. doi: 10.1111/1556-4029.14975. Epub 2022 Jan 13.
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.
Yang H, Zhou B, Deng H, Prinz M, Siegel D. Body fluid identification by mass spectrometry. Int J Legal Med. 2013 Nov;127(6):1065-77. doi: 10.1007/s00414-013-0848-1. Epub 2013 Mar 24.
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.
Legg KM, Powell R, Reisdorph N, Reisdorph R, Danielson PB. Discovery of highly specific protein markers for the identification of biological stains. Electrophoresis. 2014 Nov;35(21-22):3069-78. doi: 10.1002/elps.201400125. Epub 2014 Oct 1.
Van Steendam K, De Ceuleneer M, Dhaenens M, Van Hoofstat D, Deforce D. Mass spectrometry-based proteomics as a tool to identify biological matrices in forensic science. Int J Legal Med. 2013 Mar;127(2):287-98. doi: 10.1007/s00414-012-0747-x. Epub 2012 Jul 29.
Illiano A, Arpino V, Pinto G, Berti A, Verdoliva V, Peluso G, Pucci P, Amoresano A. Multiple Reaction Monitoring Tandem Mass Spectrometry Approach for the Identification of Biological Fluids at Crime Scene Investigations. Anal Chem. 2018 May 1;90(9):5627-5636. doi: 10.1021/acs.analchem.7b04742. Epub 2018 Apr 13.
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.
de Beijer RP, de Graaf C, van Weert A, van Leeuwen TG, Aalders MCG, van Dam A. Identification and detection of protein markers to differentiate between forensically relevant body fluids. Forensic Sci Int. 2018 Sep;290:196-206. doi: 10.1016/j.forsciint.2018.07.013. Epub 2018 Jul 24.
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Other Identifiers
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RECHMPL23_0098
Identifier Type: -
Identifier Source: org_study_id