Erythema MigransDIABOLYCNCT02414789
Lyme Borreliosis and Early Cutaneous Diagnostic
A study testing Skin biopsies in people with Erythema Migrans, run by University Hospital, Strasbourg, France at 7 sites in France.
Trial summary
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erythema Migrans
- What is being tested?
- Skin biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Aug 2015to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
- Patient having signed a consent
- Patient affiliated to a social security scheme
Who cannot join
- Prior treatment with antibiotics
- Erythema migrans on the face
- Bleeding disorders
- Anticoagulant treatment
- Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalo-Universitaire Jean Minjoz
Besançon
Centre Hospitalier William Morey
Chalon-sur-Saône
Hôpital Pasteur
Colmar
Hôpital E. Muller
Mulhouse
Hôpital Robert Debré
Reims
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Hôpital Bel Air
Thionville
About this study
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).
This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
- Conditions
- Erythema Migrans
- Being tested
- Skin biopsies
- Keywords
- erythema migrans, Lyme, early diagnosis, skin biomarkers, proteomics diagnostic, mass spectrometry
- Medical subject headings
- Glossitis, Benign Migratory, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsiesProcedure or surgery
Skin biopsies of patients with Lyme disease (erythema migrans) infected with Borrelia burgdorferi sensu lato will be analyzed by three diagnostic techniques : molecular technique (PCR), biological technique (culture of the bacteria) and proteomics technique (SRM/ MS-MS)
| Study group | Role | What they receive |
|---|---|---|
| SRM / MS-MS | Experimental | Not described Receives: Procedure: Skin biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Measured: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study start6 Aug 2015
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erythema MigransStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414789
- Sponsor's protocol ID
- 6084
- Acronym
- DIABOLYC
- Status last verified
- Sep 2025
- First submitted
- 8 Apr 2015
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cantero P, Ehret-Sabatier L, Lenormand C, Hansmann Y, Sauleau E, Zilliox L, Westermann B, Jaulhac B, Mutter D, Barthel C, Perdu-Alloy P, Martinot M, Lipsker D, Boulanger N. Detection of Borrelia burgdorferi sensu lato by proteomics: a complementary diagnosis tool on erythema migrans biopsies. Clin Microbiol Infect. 2025 Jan;31(1):78-86. doi: 10.1016/j.cmi.2024.10.014. Epub 2024 Oct 23.
PubMed 39454756
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyme Borreliosis and Early Cutaneous Diagnostic
- ClinicalTrials.gov ID
- NCT02414789
- Acronym / sponsor ID
- DIABOLYC / 6084
- Conditions
- Erythema Migrans
- Keywords
- erythema migrans, Lyme, early diagnosis, skin biomarkers, proteomics diagnostic, mass spectrometry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).
This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SRM / MS-MS | Experimental | Procedure: Skin biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
- Patient having signed a consent
- Patient affiliated to a social security scheme
Key exclusion criteria (5 listed)
- Prior treatment with antibiotics
- Erythema migrans on the face
- Bleeding disorders
- Anticoagulant treatment
- Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
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 |
|---|---|---|
| Skin biopsiesSkin biopsies of patients with Lyme disease (erythema migrans) infected with Borrelia burgdorferi sensu lato will be analyzed by three diagnostic techniques : molecular technique (PCR), biological technique (culture of the bacteria) and proteomics technique (SRM/ MS-MS) | Procedure or surgery | SRM / MS-MS |
Primary outcome
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia
Time frame: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39454756Cantero P, Ehret-Sabatier L, Lenormand C, Hansmann Y, Sauleau E, Zilliox L, Westermann B, Jaulhac B, Mutter D, Barthel C, Perdu-Alloy P, Martinot M, Lipsker D, Boulanger N. Detection of Borrelia burgdorferi sensu lato by proteomics: a complementary diagnosis tool on erythema migrans biopsies. Clin Microbiol Infect. 2025 Jan;31(1):78-86. doi: 10.1016/j.cmi.2024.10.014. Epub 2024 Oct 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsies in people with Erythema Migrans, run by University Hospital, Strasbourg, France at 7 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia (time frame: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).). 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 NCT02414789, which also lists 1 linked publication.
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 13 Jul 2026.