NCT04920162Completed
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 4 Jun 2021
- Start date
- Dec 2021
- Primary completion date
- Apr 2024
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Melanoma
- NCT number
- NCT04920162
What you commit to
- Study type: Interventional
- Participants enrolled: 10
- From Dec 2021 to the primary completion date, Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient for whom a combination of anti-PD1 and anti-CTLA-4 immunotherapy is being considered. (melanoma)
- Concomitant intake of oral immunosuppressive therapy or topical corticosteroid therapy (on vitiligo lesions) or systemic
- History of treatment with anti-CTLA-4, anti-PD-1 or anti-PD-L1, including in an adjuvant situation
- Patient participating or having participated in another clinical drug trial during the month preceding inclusion
Other illness
- Patient being allergic to gluten (vitiligo)
- Disease not measurable according to RECIST 1.1 criteria (melanoma)
- Active autoimmune disease: chronic inflammatory bowel disease and patients with autoimmune disease that is or has been symptomatic
- Patients with autoimmune motor neuropathy
- Organ transplant patients (kidney, liver, lung, heart, etc.)
- Patient with a history of clinically significant allergy
- HIV and / or HCV and / or HBV positive serologies
- Patient's refusal to do an HIV, HBV, HCV serology
Other
- Segmental or mixed vitiligo (vitiligo)
- Photodermatosis or taking a photosensitizing treatment (vitiligo)
- Melanoma of unknown origin (melanoma)
- Ocular melanoma or mucous melanoma (melanoma)
- Patient with brain metastases, symptomatic or not (melanoma)
- Vulnerable people (minors, patients under guardianship or guardianship, deprived of their liberty, under the protection of justice, etc.)
- Women who are pregnant or breastfeeding or who planned to become pregnant during the course of the study.
Who the study is looking for
- Patient diagnosed with non-segmental vitiligo (vitiligo)
- Vitiligo affecting more than 5% of the total body surface (vitiligo)
- Patient with unresectable stage III or stage IV skin melanoma confirmed histologically (melanoma)
- Treatment-naïve patient with an indication for anti-PD1 mono-immunotherapy with nivolumab or pembrolizumab regardless of their BRAF status (melanoma)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.