eye melanoma uveal melanoma
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: I-1. Patients must be *18 years of age. I-3. Patients with either primary UM completing I-4 to I-6 inclusion criteria or with lesions highly suspected of metastases from uveal melanoma and completing I-7 to I-10 inclusion criteria. I-4. Patients presenting an untreated primary UM diagnosed by local investigator and at a high risk of developing metastatic disease. I-5. Patients undergoing a fine-needle biopsy aspiration for diagnosis procedure or an enucleation for therapeutic procedure in the setting of its care. I-6. Tumour tissue should be obtained before any local radiation therapy or systemic treatment. I-7. Patients presenting lesions highly suspected of metastases from uveal melanoma. Histological confirmation of uveal melanoma metastasis is mandatory and may be done by a local pathologist after inclusion in the study. If the suspected lesions are not uveal melanoma metastases after histological analysis the patient will not be eligible for follow-up analysis. I-8. Patients undergoing a diagnostic procedure for histological confirmation of metastasis (for instance percutaneous fine needle biopsy, partial hepatectomy etc.) in the setting of routine care. Patients considered by their clinicians, because of any medical condition, at high-risk of procedure complication linked to study sampling should not be included. I-9. Tumor tissue should be obtained before any systemic treatment for metastatic disease. I-10. Metastatic patients will be included even if they have had previous surgeries for metastatic UM.
Exclusion criteria
Exclusion criteria: E-1. Patients presenting a melanoma arising from another tissue than choroid (e.g. conjunctiva, skin, mucosa etc.). E-2. Patients with other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ. Patients with a history of localized malignancy diagnosed over 5 years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease. E-3. Previous systemic treatment for metastatic UM. E-4. Patients not consenting to tissue or clinical data collection for research purpose E-5. Patients known to suffer from HIV, active tuberculosis, active hepatitis C, B or other active viral hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Genetic, molecular and immunologic characteristics of primary tumor, metastases and peripheral blood of patients diagnosed with uveal melanoma. Analysis of molecular and immunologic experimental therapies in in vitro and in vivo models. | — |
Countries
Netherlands
Outcome results
None listed