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

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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