NCT02828202Recruiting
Follow-up of a National Cohort of Melanoma Resectable Stage II, Stage III or IV Patients or Unresectable Primary
Constitution of a National Cohort of Patients With Metastatic Melanoma Resectable Stage II or Stage III or IV or Unresectable Primary With the Objective of Setting up Epidemiological Monitoring and Clinico-biological Database, MELBASE
Source: ClinicalTrials.gov · Last updated 11 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 6000 (estimated)
- First submitted
- 20 Oct 2015
- Start date
- Feb 2013
- Primary completion date
- Mar 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Melanoma
- NCT number
- NCT02828202
What you commit to
- Study type: Observational
- Planned participants: 6000
- From Feb 2013 to the primary completion date, Mar 2026
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients refusal. Choroid melanoma. Resectable stage 1 melanoma. Stage 4, unresectable primitive or unresectable stage 3 melanoma. Patients under guardianship and under trusteeship.
- Cohort patients with Unresectable stage III or stage IV (resectable or not) or unresectable primary:
- Resectable stage 1, 2 or 3 melanoma. Patients refusal. Choroid melanoma. Patients under guardianship and under trusteeship.
Who the study is looking for
- 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).
- 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).
Criteria the registry did not label
- Cohort Patients with Resectable stage II or III
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU D'amiens Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Ch Annecy Genevois Coordinator of this site? Confirm its status | Annecy | France | Recruiting |
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Avicennes Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| CHU de Bordeaux, Hôpital Saint-André Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU de Bordeaux - Hopital Haut Leveque Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Ambroise Paré Coordinator of this site? Confirm its status | Boulogne-Billancourt | France | Active, not recruiting |
| CHU de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| CHU de CAEN Coordinator of this site? Confirm its status | Caen | France | Active, not recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Henri Mondor Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| CHU de DIJON Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| CHU de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| CHRU de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| AP-HM - Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CHU de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nancy Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| CHU de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHRU de Nîmes Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Bichat Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hopital Saint-Louis, centre d'oncodermatologie Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| CLCC Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| CHU de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| CHU de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.