An interventional study of Biospecimen into patients who had skin diseases in Melanoma and Vitiligo, sponsored by Centre Hospitalier Universitaire de Nice. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Basic science
Skin diseases can have various origins. However, a number of them are linked to an imbalance in the immune system which will lead to either an excessively strong autoimmune response or a complete lack of response against cancer cells. Indeed, both melanoma and vitiligo are pathologies where the immune system plays an important role in the progression of the disease.
Advanced stage melanoma (metastatic lymph node and / or visceral) have a poor prognosis. Although targeted therapies and immunotherapies have improved the outcome for patient however significant proportion of these patients (\~ 50%) developed resistance to therapies.
Vitiligo is a relatively common dermatosis affecting approximately 0.5% to 1% of the French population. Vitiligo results from the destruction of the melanocytes by the immune system. It is manifested by acquired depigmented macules, well limited and asymptomatic. Patients suffering from this condition have a marked decrease in their quality of life. There has been shown a strong link between vitiligo and melanoma. Indeed, patients with melanoma who develop vitiligo (\~ 9% of patients treated with anti-PD-1 drugs) have a better prognosis compared to patients who do not develop vitiligo.
Interestingly, in melanoma cases where the immune system is inactive, the investigators have identified a new molecule secreted by melanoma cells, ITGBL1, leading to the exclusion of immune cells, decreased cytokines secretion and decreased immune cell activation. It is therefore essential to better understand the regulatory mechanism of the immune system in patients with vitiligo or in patients with melanoma treated by immunotherapy in order to be able to propose new therapeutic solutions for these patients.
No study to date has investigated the expression of ITGBL1 and serum inflammatory markers during the development of melanoma. Likewise in vitiligo, if a loss of ITGBL1 is observed, new treatments could be developed in order to limit the progression of the disease by re-expressing this protein.
Thus, the investigators exploratory study will provide the first answers to the predictive value of these markers for these pathologies in order to adapt and develop new treatments.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 10 is below the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Centre Hospitalier Universitaire de Nice is the lead sponsor of 709 studies on the registry; 176 are open to participants now.
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Exclusion Criteria:
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
Other: Biospecimen into patients who had skin diseases
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
Changes in blood ITGBL1 expression during immunotherpay
ITGBL1 expression will be measured from the plasma of patients and compared immunotherpy response based on scanner analysis according to RECIST1.1 criteria, and compared to ITGBL1 expression in vitiligo patients or healthy controls
Time frame: 12 months
Changes in cytokine CXCL9 expression in plasma
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Time frame: 12 months
Changes in cytokine CXCL10 expression in plasma
Elisa of different cytokines will be assessed in ng/ml from plasma of patients with melanoma, vitiligo or healthy controls
Time frame: 12 months
Immune cells activity
Immune cells will be isolated from the blood of all subjects and lytic activity against tumor cells will be assessed and compared to immune system activity response from the same patients
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nice