An observational study in Assessment, Self, sponsored by Sohag University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Sohag University · Observational
Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology.
Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls.
The aims of this study are:
To compare CIRP levels according to LP severity. A cross-sectional study will be conducted on 40 patients with LP and 40 age and gender matched healthy controls. Diagnosis of LP will be clinically and will be confirmed by dermoscopy.
Methods of the study:
Evaluation of CIRP expression:
Every participant in this study will be subjected to both blood sampling and skin biopsy taking in the same session, then each sample will be processed separately and blindly at the Clinical Pathology, and Histology Departments as following:
Three ml venous blood sample will be taken from every one of the two studied groups in a free anticoagulant tube, enabling the blood to be coagulated. After 30 minutes of leaving the tube at room temperature till coagulation, then samples will be centrifuged (at 3000 rpm for 15 min) and the resultant serum will be stored at -80c until testing (22). Serum CIRP levels will be measured using an enzyme-linked immunosorbent assay analysis (ELISA) kit.
Histopathological assessment of H\&E-stained sections:
Sections stained with H\&E will be evaluated under the light microscope to confirm the diagnosis of LP and to asses epidermal and dermal changes.
The CIRP immunostaining will be assessed separately and blindly in LP lesion and control cases. Epidermal and dermal cells will be assigned positive by the presence of brownish coloration detected by DAB reaction either in the cytoplasm or nuclei in ≥ 1 stained cells (25).
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 17 observational studies indexed under Lichen Planus.
Browse Lichen Planus studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
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40 patients with LP and 40 age and gender matched healthy controls who will attend the Dermatology Outpatient Clinics, Sohag University Hospitals. Diagnosis of LP will be clinically and will be confirmed by dermoscopy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1 . Pregnancy and lactation. 2. Patients with any infections or sepsis. 3. Patients with any other dermatological diseases associated with increased CIRP levels (eg. psoriasis, vitiligo or alopecia areata).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
40 cases with lichen planus from who skin biopsies and blood samples will be taken to assess cold inducible RNA binding protein levels in both tissues and serum.
40 healthy controls from who skin biopsies and blood samples will be taken to assess serum and tissue levels of cold-inducible RNA binding protein and compare them to active cases.
Assessment of cold-inducible RNA binding protein levels in serum and tissue
Skin biopsies and blood samples will be taken to assess CIRBP levels
Time frame: about one year
Start is estimated for Feb 2024; primary completion for Feb 2025, 12 months later.
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