Lichen PlanusNCT03796806
Methods Validation Assessment for Study of Inflammatory Skin Disease
An observational study of Lichen Planus, run by Mayo Clinic at 1 site in United States.
Trial summary
1. Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease 2. Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 14 Jan 2019
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo Clinic-Rochester.
Who may be able to join
- Adults >18 years with active cutaneous lichen planus with capacity to consent.
Who cannot join
- Concurrent skin infection
- Wound healing disturbances
- Patients on systemic immunosuppressive medications.
- Lidocaine allergy
- Platelets <10,000
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
- Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease
- Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.
Read the detailed description
The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.
Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality.
- Conditions
- Lichen Planus
- Keywords
- lichen planus, proteomics, xenograft model for lichen planus
- Medical subject headings
- Lichen Planus
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.
Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.
Measured: 8 months
Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model
Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.
Measured: 8 months
Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model
Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start14 Jan 2019
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia S. Lehman, Mayo Clinic
- Investigators
- Julia S Lehman, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796806
- Sponsor's protocol ID
- 18-002404
- Status last verified
- Oct 2021
- First submitted
- 22 Oct 2018
- Last updated
- 8 Oct 2021
- 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 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods Validation Assessment for Study of Inflammatory Skin Disease
- ClinicalTrials.gov ID
- NCT03796806
- Acronym / sponsor ID
- 18-002404
- Conditions
- Lichen Planus
- Keywords
- lichen planus, proteomics, xenograft model for lichen planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 8 Jan 2019 (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.
- Assess validity of methods involved in molecular studies of the skin in inflammatory skin disease
- Assess feasibility of methods for grafting fresh human skin (normal and diseased with inflammatory skin disease) onto an established xenograft murine model.
Detailed description
The use of fixed tissue specimens for research studies is attractive, because a large number of relevant specimens can be collected quickly from tissue registry. There is a current lack of knowledge regarding to what extent formalin fixation alters the identification of proteins in the skin with inflammatory dermatoses. This information would be important to assess when determining the limitations (or potentially lack thereof) of using fixed specimens in research.
Collaborators have successfully developed a murine model that can accept human skin xenografts. While those investigators have successfully demonstrated transplantation of healthy skin onto mice, it is unknown whether skin affected by inflammatory disease can be transplanted and, if so, whether the inflammatory skin disease remains, whether it spreads to involve host skin, or whether it resolves. Determining feasibility of transplanting inflamed human skin using this model, as well as observing the course of this inflammation, are the next steps in advancing this potentially invaluable research modality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic patients with active lichen planus and residing within a 50-mile radius of Mayo Clinic-Rochester.
Key inclusion criteria (1 listed)
- Adults >18 years with active cutaneous lichen planus with capacity to consent.
Key exclusion criteria (5 listed)
- Concurrent skin infection
- Wound healing disturbances
- Patients on systemic immunosuppressive medications.
- Lidocaine allergy
- Platelets <10,000
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue.
Time frame: 8 months
Identification and quantification of proteins as obtained by liquid chromatography-mass spectrometry methods using fresh and formalin-fixed-paraffin-embedded tissue. Mass spectrometry data will be matched against a composite protein sequence database using the MyriMatch search engine and IDPicker will filter protein identification at 2% false discovery rate. QuasiTel software will process the spectral count data for the identification of differentially expressed proteins.
Viability of human inflammatory skin (lichen planus) graft in a xenograft murine model
Time frame: 8 months
Viability of diseased human graft into an established murine xenograft model by visual inspection and microscopic analysis.
Evaluation of inflammation around human inflammatory skin graft (lichen planus) and elsewhere in a established xenograft murine model
Time frame: 8 months
Assessment of inflammation around graft and elsewhere in the host by visual inspection and microscopic analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Julia S Lehman principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lichen Planus, run by Mayo Clinic at 1 site in United States.
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 1 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 8 Oct 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparative analysis of proteomes on fresh versus formalin-fixed-paraffin-embedded tissue. (time frame: 8 months). The study lists 3 primary outcomes in all. 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 8 Oct 2021.