Evaluating IL4I1 as a Prognostic Marker in Melanoma Patients
Impact of the IL4I1 Enzyme Expression in Patients With Cutaneous Melanoma: Prognostic Value and/or Role in Resistance to Current Immunotherapy and Targeted Therapy
This study is testing if measuring a specific enzyme in the blood and tissues of melanoma patients can help predict how their cancer will progress and respond to treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Paris, Ile De France) |
| Trial ID | NCT04253080 on ClinicalTrials.gov |
What this trial studies
This study aims to characterize and quantify immune cells expressing the IL4I1 enzyme in the blood and tissues of melanoma patients. It will compare the presence of IL4I1 positive cells in patients with varying disease progression and treatment responses to immunotherapy and targeted therapies. The study will utilize immunofluorescence and immunohistochemistry techniques to assess the correlation between IL4I1 levels and cancer recurrence risk. By identifying new prognostic markers, the research seeks to improve treatment strategies for melanoma patients.
Who should consider this trial
Good fit: Ideal candidates include patients with either thin or thick cutaneous melanoma who are being monitored for recurrence.
Not a fit: Patients with other concomitant cancers requiring systemic treatment at the time of melanoma diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better prognostic tools and treatment strategies for melanoma patients, potentially improving their outcomes.
How similar studies have performed: While the approach of identifying new prognostic markers in melanoma is being explored, the specific focus on IL4I1 as a predictive marker is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * group 1: patients with primary thin melanoma (Breslow thickness less than or equal to1 mm) monitored for 10 years, having relapsed or not within 10 years after the diagnosis. * patients with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma * patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study * patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research * group 2: patients with primary thick melanoma (Breslow greater than or equal to 3 mm) monitored for 5 years, having relapsed or not within 5 years after diagnosis. * patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma * patient or patient's family (in case of death) informed of the objectives and modalities of the study and not opposed to participation in the study * patient or patient's family (in case of death) not opposed to the use of part of the skin sample previously taken for the present research * group 3: patient with melanoma (stages III or IV inoperable) and who are treated with immunotherapy and / or biotherapy * patient with no other concomitant cancers requiring systemic treatment at the time of diagnosis of primary melanoma and initiation of systemic treatment for melanoma * patient informed of the objectives and modalities of the study and having given informed and written consent to participate in the study Exclusion Criteria: * groups 1 and 2: patient or family of the patient opposed (e) that part of the primary melanoma taken previously is used in the context of the present project * group 3 : * refusal of the patient to participate in the study * patient unable to understand the study and sign consent * patient with a known contraindication to xylocaine * patient not affiliated to a social security system (beneficiary or beneficiary's right) * adult subject to a legal protection measure
Where this trial is running
Paris, Ile De France
- Dermatology department — Paris, Ile De France, France (Recruiting)
Study contacts
- Principal investigator: Armelle Blondel, MD, PhD — Institut National de la Santé Et de la Recherche Médicale, France
- Study coordinator: Nora Kramkimel, MD, PhD
- Email: nora.kramkimel@aphp.fr
- Phone: +33 1 58 41 19 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.