LeprosyDoes not existNCT07515989
Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
A study testing Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate in people with Leprosy and Leprosy Neuropathy, run by University of Brasilia at 1 site in Brazil.
Trial summary
Brief Summary Leprosy is a chronic granulomatous infectious disease caused by *Mycobacterium leprae* or *Mycobacterium lepromatosis*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Leprosy, Leprosy Neuropathy, Leprosy, Multibacillary
- What is being tested?
- Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals aged 14 years or older;
- Clinical suspicion of leprosy based on dermatologic or neurologic examination OR;
- Presence of peripheral nerve enlargement or skin lesions compatible with leprosy;
- Ability to provide written informed consent.
- -
Who cannot join
- Previous treatment for leprosy;
- Contraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy);
- Local infection at the puncture site;
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
University Hospital of Brasília
Brasília, Federal District, 70.830-200
Daniel Barroso, Dr, 61998591155 ext. +556120285530, danielhbarroso@gmail.com
Daniel H Barroso, dr, +556120285481, danielhbarroso@ebserh.gov.br
About this study
Brief Summary
Leprosy is a chronic granulomatous infectious disease caused by *Mycobacterium leprae* or *Mycobacterium lepromatosis*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. The diagnosis of leprosy is primarily clinical and epidemiological, supported by laboratory methods such as bacilloscopy and biopsy; however, these tests have limited sensitivity, particularly due to the bacillus' tropism for peripheral nerve structures.
Read more
Ultrasonography has emerged as a non-invasive imaging method capable of detecting morphological changes in peripheral nerves, including nerve enlargement, fascicular abnormalities, and inflammatory hypervascularization. Despite its diagnostic value, ultrasonography alone cannot detect the presence of the bacillus.
This prospective cohort study aims to evaluate the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using subcutaneous perineural aspirate. Patients with suspected leprosy attending the Leprosy Outpatient Clinic at the University Hospital of Brasília will undergo clinical evaluation, ultrasound examination of the ulnar nerves, and ultrasound-guided subcutaneous perineural aspirate for molecular detection of *Mycobacterium leprae* DNA and RNA using real-time PCR and RT-PCR.
Participants will be followed for one year, with assessments performed at diagnosis and after one year of treatment. The study will compare clinical, imaging, and molecular findings to determine whether perineural subcutaneous aspirate combined with ultrasonography improves early detection and diagnostic accuracy compared with conventional methods such as bacilloscopy and biopsy.
The study aims to contribute to improved diagnostic strategies for leprosy, enabling earlier detection of neural involvement and potentially reducing disease transmission and long-term disability.
Read the detailed description
Leprosy is a chronic infectious disease caused by Mycobacterium leprae and is characterized by skin and peripheral nerve involvement. Neural impairment is the main determinant of disability and long-term morbidity. Early diagnosis remains challenging because current diagnostic methods have important limitations. Slit-skin smear microscopy and skin biopsy have low sensitivity in many clinical settings, especially in paucibacillary and primary neural forms. Nerve palpation is widely used but lacks reproducibility and does not distinguish among etiologies of neuropathy. Nerve biopsy, although more precise in selected cases, is invasive and may cause permanent neurological sequelae.
High-resolution ultrasonography has emerged as a promising tool for evaluation of leprosy neuropathy because it allows objective assessment of peripheral nerve cross-sectional area, asymmetry, fascicular abnormalities, and intraneural or epineural hypervascularity using Doppler. However, ultrasound cannot directly detect the bacillus.
Molecular methods have expanded the diagnostic possibilities in leprosy. Real-time PCR targeting the repetitive element RLEP can detect M. leprae DNA with high sensitivity. However, DNA detection alone does not distinguish viable from non-viable bacilli. Detection of RNA by RT-PCR, including targets such as 16S rRNA and sodA, may provide evidence of bacillary viability because RNA degrades rapidly after cell death. This approach may improve treatment monitoring and refine the concept of cure.
The present study proposes a minimally invasive strategy based on ultrasound-guided ulnar perineural subcutaneous aspirate. Biological material will be collected adjacent to the affected nerve, avoiding direct nerve biopsy and potentially increasing the sensitivity of molecular detection in the neural microenvironment. Participants with suspected leprosy will be assessed clinically, by high-resolution ultrasound of the ulnar nerves, and by molecular detection of M. leprae DNA and RNA in aspirated material. They will be evaluated at baseline, near the time of diagnosis, and after one year of treatment.
The main objective is to determine the diagnostic accuracy of ultrasound-guided perineural aspirate PCR/RT-PCR compared with conventional methods. Secondary objectives include correlation of ultrasound abnormalities with molecular positivity, assessment of bacillary viability over time, and development of workflows potentially applicable to the public health system, including referral centers and settings using portable ultrasound.
- Conditions
- Leprosy, Leprosy Neuropathy, Leprosy, Multibacillary, Leprosy--Patients, Mononeuropathies, Polyneuropathies
- Being tested
- Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate
- Keywords
- Leprosy, Slit Skin smear, Polimerase chain reaction, RLEP, 16S, Sod, Periferal Nerve Ultrassound
- Medical subject headings
- Leprosy, Leprosy, Multibacillary, Mononeuropathies, Polyneuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Ulnar Perineural Subcutaneous AspirateDiagnostic test
Ultrasound-guided subcutaneous aspirate performed adjacent to the ulnar nerve using a 26G needle and sterile saline, followed by molecular analysis for detection of Mycobacterium leprae DNA and RNA by real-time PCR and RT-PCR.
| Study group | Role | What they receive |
|---|---|---|
| Suspected Leprosy Cohort | Experimental | Participants with suspected leprosy undergoing clinical evaluation, peripheral nerve ultrasound, ultrasound-guided ulnar perineural subcutaneous aspirate, and molecular testing for detection of Mycobacterium leprae DNA and RNA. Receives: Diagnostic Test: Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of perineural aspirate PCR for detection of Mycobacterium leprae
Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of PCR performed on ultrasound-guided perineural aspirate will be calculated using the WHO leprosy composite reference standard as the gold standard. Results will be expressed as proportions with 95% confidence intervals. The overall accuracy will be the main outcome
Measured: Baseline diagnostic evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies of the same condition, open and under way.
- 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Brasilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Holanda Barroso, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515989
- Sponsor's protocol ID
- 85116624.2.0000.5558
- Acronym
- Does not exist
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the Polymerase Chain Reaction of Ulnar Perineural Subcutaneous Aspirate Guided by Ultrasound for the Diagnosis and Monitoring of Leprosy Cure
- ClinicalTrials.gov ID
- NCT07515989
- Acronym / sponsor ID
- Does not exist / 85116624.2.0000.5558
- Conditions
- Leprosy, Leprosy Neuropathy, Leprosy, Multibacillary, Leprosy--Patients, Mononeuropathies, Polyneuropathies
- Keywords
- Leprosy, Slit Skin smear, Polimerase chain reaction, RLEP, 16S, Sod, Periferal Nerve Ultrassound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- University of BrasiliaUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Apr 2026 (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.
Brief Summary
Leprosy is a chronic granulomatous infectious disease caused by *Mycobacterium leprae* or *Mycobacterium lepromatosis*, characterized by peripheral nerve involvement that may lead to progressive neurological damage, disability, and deformities if not diagnosed and treated early. The diagnosis of leprosy is primarily clinical and epidemiological, supported by laboratory methods such as bacilloscopy and biopsy; however, these tests have limited sensitivity, particularly due to the bacillus' tropism for peripheral nerve structures.
Ultrasonography has emerged as a non-invasive imaging method capable of detecting morphological changes in peripheral nerves, including nerve enlargement, fascicular abnormalities, and inflammatory hypervascularization. Despite its diagnostic value, ultrasonography alone cannot detect the presence of the bacillus.
This prospective cohort study aims to evaluate the diagnostic and prognostic accuracy of combining clinical evaluation, peripheral nerve ultrasonography, and molecular detection techniques using subcutaneous perineural aspirate. Patients with suspected leprosy attending the Leprosy Outpatient Clinic at the University Hospital of Brasília will undergo clinical evaluation, ultrasound examination of the ulnar nerves, and ultrasound-guided subcutaneous perineural aspirate for molecular detection of *Mycobacterium leprae* DNA and RNA using real-time PCR and RT-PCR.
Participants will be followed for one year, with assessments performed at diagnosis and after one year of treatment. The study will compare clinical, imaging, and molecular findings to determine whether perineural subcutaneous aspirate combined with ultrasonography improves early detection and diagnostic accuracy compared with conventional methods such as bacilloscopy and biopsy.
The study aims to contribute to improved diagnostic strategies for leprosy, enabling earlier detection of neural involvement and potentially reducing disease transmission and long-term disability.
Detailed description
Leprosy is a chronic infectious disease caused by Mycobacterium leprae and is characterized by skin and peripheral nerve involvement. Neural impairment is the main determinant of disability and long-term morbidity. Early diagnosis remains challenging because current diagnostic methods have important limitations. Slit-skin smear microscopy and skin biopsy have low sensitivity in many clinical settings, especially in paucibacillary and primary neural forms. Nerve palpation is widely used but lacks reproducibility and does not distinguish among etiologies of neuropathy. Nerve biopsy, although more precise in selected cases, is invasive and may cause permanent neurological sequelae.
High-resolution ultrasonography has emerged as a promising tool for evaluation of leprosy neuropathy because it allows objective assessment of peripheral nerve cross-sectional area, asymmetry, fascicular abnormalities, and intraneural or epineural hypervascularity using Doppler. However, ultrasound cannot directly detect the bacillus.
Molecular methods have expanded the diagnostic possibilities in leprosy. Real-time PCR targeting the repetitive element RLEP can detect M. leprae DNA with high sensitivity. However, DNA detection alone does not distinguish viable from non-viable bacilli. Detection of RNA by RT-PCR, including targets such as 16S rRNA and sodA, may provide evidence of bacillary viability because RNA degrades rapidly after cell death. This approach may improve treatment monitoring and refine the concept of cure.
The present study proposes a minimally invasive strategy based on ultrasound-guided ulnar perineural subcutaneous aspirate. Biological material will be collected adjacent to the affected nerve, avoiding direct nerve biopsy and potentially increasing the sensitivity of molecular detection in the neural microenvironment. Participants with suspected leprosy will be assessed clinically, by high-resolution ultrasound of the ulnar nerves, and by molecular detection of M. leprae DNA and RNA in aspirated material. They will be evaluated at baseline, near the time of diagnosis, and after one year of treatment.
The main objective is to determine the diagnostic accuracy of ultrasound-guided perineural aspirate PCR/RT-PCR compared with conventional methods. Secondary objectives include correlation of ultrasound abnormalities with molecular positivity, assessment of bacillary viability over time, and development of workflows potentially applicable to the public health system, including referral centers and settings using portable ultrasound.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Leprosy Cohort | Experimental | Diagnostic Test: Ultrasound-Guided Ulnar Perineural Subcutaneous AspirateParticipants with suspected leprosy undergoing clinical evaluation, peripheral nerve ultrasound, ultrasound-guided ulnar perineural subcutaneous aspirate, and molecular testing for detection of Mycobacterium leprae DNA and RNA. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals aged 14 years or older;
- Clinical suspicion of leprosy based on dermatologic or neurologic examination OR;
- Presence of peripheral nerve enlargement or skin lesions compatible with leprosy;
- Ability to provide written informed consent.
- -
Key exclusion criteria (4 listed)
- Previous treatment for leprosy;
- Contraindication to the aspiration procedure (e.g., coagulopathy or anticoagulant therapy);
- Local infection at the puncture site;
- Inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| Ultrasound-Guided Ulnar Perineural Subcutaneous AspirateUltrasound-guided subcutaneous aspirate performed adjacent to the ulnar nerve using a 26G needle and sterile saline, followed by molecular analysis for detection of Mycobacterium leprae DNA and RNA by real-time PCR and RT-PCR. | Diagnostic test | Suspected Leprosy Cohort |
Primary outcome
Diagnostic accuracy of perineural aspirate PCR for detection of Mycobacterium leprae
Time frame: Baseline diagnostic evaluation
Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy of PCR performed on ultrasound-guided perineural aspirate will be calculated using the WHO leprosy composite reference standard as the gold standard. Results will be expressed as proportions with 95% confidence intervals. The overall accuracy will be the main outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-Guided Ulnar Perineural Subcutaneous Aspirate in people with Leprosy and Leprosy Neuropathy, run by University of Brasilia at 1 site in Brazil.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of perineural aspirate PCR for detection of Mycobacterium leprae (time frame: Baseline diagnostic evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2026.