Melanoma and VitiligoVITILIMELNCT04920162
Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma
A study testing Biospecimen into patients who had skin diseases in people with Melanoma and Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma and Vitiligo
- What is being tested?
- Biospecimen into patients who had skin diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2021to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Segmental or mixed vitiligo (vitiligo)
- Photodermatosis or taking a photosensitizing treatment (vitiligo)
- Patient being allergic to gluten (vitiligo)
- Melanoma of unknown origin (melanoma)
- Ocular melanoma or mucous melanoma (melanoma)
- Patient with brain metastases, symptomatic or not (melanoma)
Show all 19Show fewer
- Disease not measurable according to RECIST 1.1 criteria (melanoma)
- Patient for whom a combination of anti-PD1 and anti-CTLA-4 immunotherapy is being considered. (melanoma)
- Active autoimmune disease: chronic inflammatory bowel disease and patients with autoimmune disease that is or has been symptomatic
- Patients with autoimmune motor neuropathy
- Concomitant intake of oral immunosuppressive therapy or topical corticosteroid therapy (on vitiligo lesions) or systemic
- Organ transplant patients (kidney, liver, lung, heart, etc.)
- Patient with a history of clinically significant allergy
- History of treatment with anti-CTLA-4, anti-PD-1 or anti-PD-L1, including in an adjuvant situation
- HIV and / or HCV and / or HBV positive serologies
- Patient's refusal to do an HIV, HBV, HCV serology
- Vulnerable people (minors, patients under guardianship or guardianship, deprived of their liberty, under the protection of justice, etc.)
- Patient participating or having participated in another clinical drug trial during the month preceding inclusion
- Women who are pregnant or breastfeeding or who planned to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)
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.
Read more
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.
- Conditions
- Melanoma and Vitiligo
- Being tested
- Biospecimen into patients who had skin diseases
- Medical subject headings
- Melanoma, Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen into patients who had skin diseasesOther
Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
| Study group | Role | What they receive |
|---|---|---|
| Skin deseases biospecimens collection | Other | Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment Receives: Other: Biospecimen into patients who had skin diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start28 Dec 2021
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma and VitiligoStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920162
- Sponsor's protocol ID
- 20-AOIP-03
- Acronym
- VITILIMEL
- Status last verified
- Nov 2024
- First submitted
- 4 Jun 2021
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for New Predictive Markers of the Immune Response in Vitiligo and Melanoma (Vitilimel Study)
- ClinicalTrials.gov ID
- NCT04920162
- Acronym / sponsor ID
- VITILIMEL / 20-AOIP-03
- Conditions
- Melanoma and Vitiligo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin deseases biospecimens collection | Other | Other: Biospecimen into patients who had skin diseasesCollect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (19 listed)
- Segmental or mixed vitiligo (vitiligo)
- Photodermatosis or taking a photosensitizing treatment (vitiligo)
- Patient being allergic to gluten (vitiligo)
- Melanoma of unknown origin (melanoma)
- Ocular melanoma or mucous melanoma (melanoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen into patients who had skin diseasesCollect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment | Other | Skin deseases biospecimens collection |
Primary outcome
Changes in blood ITGBL1 expression during immunotherpay
Time frame: 12 months
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
3 secondary outcomes
Changes in cytokine CXCL9 expression in plasma
Time frame: 12 months
Changes in cytokine CXCL10 expression in plasma
Time frame: 12 months
Immune cells activity
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen into patients who had skin diseases in people with Melanoma and Vitiligo, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in blood ITGBL1 expression during immunotherpay (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.