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

Recruiting

• Conditions: Uveal Melanoma

• Registration Number: NCT01438658
• Lead Sponsor: Hadassah Medical Organization

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 Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28
• Primary Completion: 2040-12
• Study Completion: 2040-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• diagnosis of uveal melanoma

Exclusion Criteria

• refusal to participate in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Significant increase in biomarker level that could be linked with detection of metastases by imaging	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.

Trial Locations

Locations (1)

Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center; 🇮🇱 Jerusalem, Israel