Clinical Trial: Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma

Brief Summary:

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.


Detailed Summary:
Sponsor: Hadassah Medical Organization

Current Primary Outcome: 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.


Original Primary Outcome: Change in biomarker level that is 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.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hadassah Medical Organization

Dates:
Date Received: September 15, 2011
Date Started: September 2011
Date Completion: December 2040
Last Updated: September 27, 2011
Last Verified: September 2011