Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04920162
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2021-06-04
Brief Title:
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma Vitilimel Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITILIMEL
Brief Summary:
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 05 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
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 05 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None