Clinical trial · Observational
Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma
Morphological, Genetic and Tumour Microenvironment Characterisation in Uveal Melanoma and Impact on the Development of Metastasis and Mortality.
NCT05889481CI-TRIAL-00067283MicroGenUMunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objectives of the study are the morpho-phenotypic evaluation of uveal melanoma and to identify molecular prognostic factors that may be correlated with disease severity, tumour progression and response to treatment. These objectives will be achieved through immunohistochemical and genetic analyses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytogenetic analysis on tumour tissue | Genetic | — | UNRESOLVED |
| Digital Pathology | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective cohort
- description
- Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology Unit and they finished the follow-up
- interventionNames
- Genetic: cytogenetic analysis on tumour tissue
- Biological: Digital Pathology
- label
- Prospective cohort
- description
- Patients diagnosed with uveal melanoma undergoing histological and cytogenetic analysis. The cases will be identified from patients referred to the Ocular Oncology and they still have to complete the follow-up
- interventionNames
- Genetic: cytogenetic analysis on tumour tissue
- Biological: Digital Pathology
Primary outcomes (1)
- measure
- morpho-phenotypic evaluation of uveal melanoma (Digital Pathology - array-CGH)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older; 2. Clinical and histological diagnosis of uveal melanoma; 3. Ability to obtain formalin-fixed, paraffin-embedded tissue (FFPE). 4. Availability of genetic analysis results from tumour tissue obtained by enucleation or fine-needle biopsy. 5. Follow-up of at least 5 years from enucleation or fine-needle biopsy. 6. Written informed consent to use the data for research purposes. Exclusion Criteria: 1. Age \< 18 years; 2. Lack of sufficient clinical data on selected patients. 3. Follow-up of less than 5 years. 4. Refusal to give informed consent to data processing for research purposes.
References
Publications (14)
- BACKGROUNDSingh AD, Turell ME, Topham AK. Uveal melanoma: trends in incidence, treatment, and survival. Ophthalmology. 2011 Sep;118(9):1881-5. doi: 10.1016/j.ophtha.2011.01.040. Epub 2011 Jun 24. PMID 21704381
- BACKGROUNDDamato B. Progress in the management of patients with uveal melanoma. The 2012 Ashton Lecture. Eye (Lond). 2012 Sep;26(9):1157-72. doi: 10.1038/eye.2012.126. Epub 2012 Jun 29. PMID 22744385
- BACKGROUNDKujala E, Makitie T, Kivela T. Very long-term prognosis of patients with malignant uveal melanoma. Invest Ophthalmol Vis Sci. 2003 Nov;44(11):4651-9. doi: 10.1167/iovs.03-0538. PMID 14578381
- BACKGROUNDGill HS, Char DH. Uveal melanoma prognostication: from lesion size and cell type to molecular class. Can J Ophthalmol. 2012 Jun;47(3):246-53. doi: 10.1016/j.jcjo.2012.03.038. PMID 22687301
- BACKGROUNDVan Raamsdonk CD, Bezrookove V, Green G, Bauer J, Gaugler L, O'Brien JM, Simpson EM, Barsh GS, Bastian BC. Frequent somatic mutations of GNAQ in uveal melanoma and blue naevi. Nature. 2009 Jan 29;457(7229):599-602. doi: 10.1038/nature07586. Epub 2008 Dec 10. PMID 19078957
- BACKGROUNDRobertson AG, Shih J, Yau C, Gibb EA, Oba J, Mungall KL, Hess JM, Uzunangelov V, Walter V, Danilova L, Lichtenberg TM, Kucherlapati M, Kimes PK, Tang M, Penson A, Babur O, Akbani R, Bristow CA, Hoadley KA, Iype L, Chang MT; TCGA Research Network; Cherniack AD, Benz C, Mills GB, Verhaak RGW, Griewank KG, Felau I, Zenklusen JC, Gershenwald JE, Schoenfield L, Lazar AJ, Abdel-Rahman MH, Roman-Roman S, Stern MH, Cebulla CM, Williams MD, Jager MJ, Coupland SE, Esmaeli B, Kandoth C, Woodman SE. Integrative Analysis Identifies Four Molecular and Clinical Subsets in Uveal Melanoma. Cancer Cell. 2017 Aug 14;32(2):204-220.e15. doi: 10.1016/j.ccell.2017.07.003. PMID 28810145
- BACKGROUNDJager MJ, Shields CL, Cebulla CM, Abdel-Rahman MH, Grossniklaus HE, Stern MH, Carvajal RD, Belfort RN, Jia R, Shields JA, Damato BE. Uveal melanoma. Nat Rev Dis Primers. 2020 Apr 9;6(1):24. doi: 10.1038/s41572-020-0158-0.