NCT04920162Befejeződött
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2024. nov. 22.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 10 (tényleges)
- Első benyújtás
- 2021. jún. 4.
- Kezdés
- 2021. dec. 28.
- Elsődleges befejezés
- 2024. ápr. 5.
- Fő szponzor
- Centre Hospitalier Universitaire de Nice
- Betegségek
- Melanóma
- NCT-szám
- NCT04920162
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 10
- 2021. dec. 28. és az elsődleges befejezés (2024. ápr. 5.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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
Más betegség
- 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
Egyéb
- 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.
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| CHU de Nice Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Nice | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.