NCT02828202 Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
| NCT ID | NCT02828202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Malignant Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 6,000 participants |
| Start Date | 2013-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6,000 participants in total. It began in 2013-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prevention of melanoma can be efficient but mortality remains unchanged and 15 to 20% of patients still die from melanoma. Indeed metastatic melanoma is a heterogeneous highly and multiple mutations driven cancer. Significant survival benefit was demonstrated since 2011 with anti-CTLA4 +/- programmed death-1 (anti PD1) antibodies, B-Raf proto-oncogene, serine/threonine kinase (BRAF) and MAP-ERK kinase (MEK) inhibitors. Future improvement of advanced melanoma prognosis will rely on clinico-epidemiological studies and on biological studies to validate and identify new prognostic and predictive factors based on clinico-epidemiological and histological data, genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile and functional imaging. In the context of marketing of costly innovative molecules, prospective collection of economic data on treatment and toxicity are required. Large biobanks collecting data from cohorts of advanced melanoma are mandatory for such projects. MELBASE is a French prospective national cohort enrolling advanced melanoma patients whose objectives are to : * provide an annual instrument panel with descriptive and correlative analysis of advanced melanoma patients in France including epidemiological, clinical, biological and economic characteristics * validate and identify new clinical, epidemiological, and biological prognostic factors such as genomic host and tumor alterations, tumor microenvironment characteristics, individual immunological profile in advanced melanoma * evaluate the risk-benefit, quality of life, the management cost of patients treated with validated and future treatments. The project also aims to define predictive biomarkers of response and toxicity including pharmacogenetics and tumor genetics alterations, tumor microenvironment characteristics, individual immunological profile. Patients with resectable stage II or III will be enrolled since June 2023 with a 10 years follow-up. Patients with unresectable stage III or IV (resectable or not) or unresectable primary melanoma will be enrolled prospectively since March 2013 with a 10 years follow-up (up to 6000 patients) from 27 French centers.
Eligibility Criteria
1. Cohort Patients with Resectable stage II or III Inclusion Criteria: Patients diagnosed with resectable stage IIA/IIB/IIC or III melanoma, confirmed by histological exam. Naïve of systemic treatment for resectable stage II or III. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria). Aged ≥ 18 years. Consenting to participate (signed informed consent). Exclusion Criteria: Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship. 2. Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary: Inclusion Criteria: Patients diagnosed with an advanced melanoma, confirmed by histological exam. Unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma ; or patients treated by neoadjuvant treatment (exceptional) Naïve of systemic treatment for unresectable primitive or unresectable stage III or stage IV (resectable or not) melanoma, except adjuvant treatment. Whose metastatic tumoral material can be collected by the Biological Resource Centers (optional criteria). Aged ≥ 18 years. Consenting to participate (signed informed consent). Exclusion Criteria: Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.
Contact & Investigator
Celeste Lebbe, MD, PhD
STUDY DIRECTOR
AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris
Frequently Asked Questions
Who can join the NCT02828202 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02828202 currently recruiting?
Yes, NCT02828202 is actively recruiting participants. Contact the research team at celeste.lebbe@aphp.fr for enrollment information.
Where is the NCT02828202 trial being conducted?
This trial is being conducted at Amiens, France, Annecy, France, Besançon, France, Bobigny, France and 11 additional locations.
Who is sponsoring the NCT02828202 clinical trial?
NCT02828202 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Celeste Lebbe, MD, PhD at AP-HP, Hopital Saint-Louis, centre d'oncodermatologie, Paris. The trial plans to enroll 6,000 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.