Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma (UM)
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|ClinicalTrials.gov Identifier: NCT01438658|
Recruitment Status : Recruiting
First Posted : September 22, 2011
Last Update Posted : September 28, 2011
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.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2040|
|Estimated Study Completion Date :||December 2040|
A cohort of all the patients.
- 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 ]Serum will be taken on every clinic visit from the day of diagnosis and on. Change in biomarker level will be assessed from one visit to the previous one, and correlated with imaging information on detection of metastases.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438658
|Contact: Shahar Frenkel, MD, PhDfirstname.lastname@example.org|
|Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Shahar Frenkel, MD, PhD +972-2-6776579 email@example.com|
|Principal Investigator: Shahar Frenkel, MD,PhD|
|Principal Investigator:||Shahar Frenkel, MD, PhD||Hadassah Medical Organization|