Brief Title
Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma
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.
Study Type
Observational
Primary Outcome
Significant increase in biomarker level that could be linked with detection of metastases by imaging
Condition
Uveal Melanoma
Study Arms / Comparison Groups
All
Description: A cohort of all the patients.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
250
Start Date
September 2011
Completion Date
December 2040
Primary Completion Date
December 2040
Eligibility Criteria
Inclusion Criteria:
- diagnosis of uveal melanoma
Exclusion Criteria:
- refusal to participate in the study
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Shahar Frenkel, MD, PhD, +972-2-6776579, [email protected]
Location Countries
Israel
Location Countries
Israel
Administrative Informations
NCT ID
NCT01438658
Organization ID
001-HMO-CTIL
Responsible Party
Sponsor
Study Sponsor
Hadassah Medical Organization
Study Sponsor
Shahar Frenkel, MD, PhD, Principal Investigator, Hadassah Medical Organization
Verification Date
September 2011