Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Uveal Melanoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Uveal melanoma is the most common primary intraocular tumor in adults. The local treatment is effective, but patients still die of metastatic disease. It has been shown that early diagnosis of a few isolated metastases can result in a clean surgical excision of the metastases and an extension of the expected survival from 7-12 months to over 10 years on some patients. Many serum biomarkers are employed in Oncology. It makes sense to try the relevant ones in the diagnosis of metastatic uveal melanoma. The investigators hypothesis is that a soluble serum biomarker level changes upon development of metastatic disease either by secretion by the tumor cells themselves or by their environment. Detection of changes in biomarker level may lead to the diagnosis of metastases before they can be detected by imaging modalities, thus allowing for early treatment of the metastases and a better chance of success.
Primary outcome measures
- Significant increase in biomarker level that could be linked with detection of metastases by imaging [Time frame: up to 12 months before diagnosis of metastases]
Eligibility criteria
Inclusion criteria
- diagnosis of uveal melanoma
Exclusion criteria
- refusal to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Israel · 1 center
- Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center — Jerusalem
Publications
- Frenkel S, Nir I, Hendler K, Lotem M, Eid A, Jurim O, Pe'er J. Long-term survival of uveal melanoma patients after surgery for liver metastases. Br J Ophthalmol. 2009 Aug;93(8):1042-6. doi: 10.1136/bjo.2008.153684. Epub 2009 May 7. PMID 19429579
- Mariani P, Piperno-Neumann S, Servois V, Berry MG, Dorval T, Plancher C, Couturier J, Levy-Gabriel C, Lumbroso-Le Rouic L, Desjardins L, Salmon RJ. Surgical management of liver metastases from uveal melanoma: 16 years' experience at the Institut Curie. Eur J Surg Oncol. 2009 Nov;35(11):1192-7. doi: 10.1016/j.ejso.2009.02.016. Epub 2009 Mar 28. PMID 19329272
- Haritoglou I, Wolf A, Maier T, Haritoglou C, Hein R, Schaller UC. Osteopontin and 'melanoma inhibitory activity': comparison of two serological tumor markers in metastatic uveal melanoma patients. Ophthalmologica. 2009;223(4):239-43. doi: 10.1159/000206139. Epub 2009 Mar 6. PMID 19270465
Identifiers
NCT: NCT01438658 · 001-HMO-CTIL