Sexual AssaultSIMSNCT06183385
Detection of Saliva by Immunoaffinity and Mass Spectrometry
A study testing Saliva collection, Vaginal secretion collection and IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry in people with Sexual Assault, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Assault
- What is being tested?
- Saliva collection, Vaginal secretion collection and IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Specific Salivary Proteins by Immunoaffinity and Mass Spectrometry
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.
Read the 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.
- Conditions
- Sexual Assault
- Being tested
- Saliva collection, Vaginal secretion collection, IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry
- Keywords
- saliva, proteins, biomarkers, mass spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva collectionOther
Collection of 2 samples of 1.5 to 2mL of saliva by passive salivation in healthy volunteers
Vaginal secretion collectionOther
Collection of vaginal secretions with 2 dry swabs in women
IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Saliva | Other | 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. Receives: Other: Saliva collection; Other: IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry |
| Vaginal secretions | Other | 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. Receives: Other: Vaginal secretion collection; Other: IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility between saliva samples
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
Measured: 3 months
Intermediate fidelity between technicians on saliva samples
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.
Measured: 3 months
Secondary outcomes (5)
Reproducibility between vaginal samples soaked with saliva
Intra-assessor agreement on vaginal samples soaked with saliva
The secondary endpoints, will consist of repeating the primary endpoints (i.e. reproducibility and intermediate fidelity) on the vaginal samples impregnated with sperm or not.
Again, the same sample will be tested several times (between 3 or 4) to see if the results come back similar.
Measured: 3 months
Intermediate fidelity between technicians on vaginal samples soaked with saliva
: Inter-assessor agreement (Cohen's kappa coefficient) on vaginal samples soaked with saliva
The secondary endpoints, will consist of repeating the primary endpoints (i.e. reproducibility and intermediate fidelity) on the vaginal samples impregnated with sperm or not.
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.
Measured: 3 months
Analytical Sensibility
Lowest saliva concentration (µL) detected by the method on saliva samples and on vaginal samples soaked with saliva in controlled condition
Measured: 3 months
Diagnostic sensibility
Analysis of saliva samples and vaginal samples soaked with saliva in controlled condition, to determine the rate of detection of true positives and false negatives
Measured: 3 months
Diagnostic specificity
Analysis of vaginal samples and dry samples in controlled condition, to determine the rate of false positives and true negatives.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start15 Jan 2024 (estimated)
- Primary completion15 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Sexual AssaultStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Antoine PEYRON, PI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183385
- Sponsor's protocol ID
- RECHMPL23_0098
- Acronym
- SIMS
- Status last verified
- Dec 2023
- First submitted
- 18 Aug 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29734053Vandenberg 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.
PubMed 16566772Blanchard 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.
PubMed 35023573Sato 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.
PubMed 35446574Yang 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.
PubMed 23525663Brown 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.
PubMed 33289932Legg 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.
PubMed 25070728Van 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.
PubMed 22843116Illiano 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.
PubMed 29579379Legg 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.
PubMed 27943336de 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.
PubMed 30071450
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Specific Salivary Proteins by Immunoaffinity and Mass Spectrometry
- ClinicalTrials.gov ID
- NCT06183385
- Acronym / sponsor ID
- SIMS / RECHMPL23_0098
- Conditions
- Sexual Assault
- Keywords
- saliva, proteins, biomarkers, mass spectrometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saliva | Other | Other: Saliva collection, Other: IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometryCollection 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. |
| Vaginal secretions | Other | Other: Vaginal secretion collection, Other: IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometryIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Saliva Samples
- Men and women aged 18 or more
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saliva collectionCollection of 2 samples of 1.5 to 2mL of saliva by passive salivation in healthy volunteers | Other | Saliva |
| Vaginal secretion collectionCollection of vaginal secretions with 2 dry swabs in women | Other | Vaginal secretions |
| IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometrysample 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. | Other | Saliva, Vaginal secretions |
Primary outcome
Reproducibility between saliva samples
Time frame: 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
Time frame: 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.
5 secondary outcomes
Reproducibility between vaginal samples soaked with saliva
Time frame: 3 months
Intermediate fidelity between technicians on vaginal samples soaked with saliva
Time frame: 3 months
Analytical Sensibility
Time frame: 3 months
Diagnostic sensibility
Time frame: 3 months
Diagnostic specificity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- BackgroundLOI 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
- Background: PubMed 29734053Wornes 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.
- Background: PubMed 16566772Vandenberg 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.
- BackgroundBlanchard 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.
- Background: PubMed 35023573Davidovics 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.
- Background: PubMed 35446574Sato 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.
- Background: PubMed 23525663Yang 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.
- Background: PubMed 33289932Brown 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.
- Background: PubMed 25070728Legg 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.
- Background: PubMed 22843116Van 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.
- Background: PubMed 29579379Illiano 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.
- Background: PubMed 27943336Legg 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Antoine PEYRON, PI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saliva collection, Vaginal secretion collection and IP-LC-MS/MS : immunoprecipitation enrichment with liquid chromatography coupled to tandem mass spectrometry in people with Sexual Assault, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Antoine PEYRON, PI (04 67 33 85 86 ext. +33, pa-peyron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility between saliva samples (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06183385, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.