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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01438658
Recruitment Status : Recruiting
First Posted : September 22, 2011
Last Update Posted : September 28, 2011
Information provided by (Responsible Party):
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.

Condition or disease
Uveal Melanoma

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
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.

Primary Outcome Measures :
  1. 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
sera from patients

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed with uveal melanoma being treated at our center

Inclusion Criteria:

  • diagnosis of uveal melanoma

Exclusion Criteria:

  • refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438658

Contact: Shahar Frenkel, MD, PhD +972-2-6776579

Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center Recruiting
Jerusalem, Israel, 91120
Contact: Shahar Frenkel, MD, PhD    +972-2-6776579   
Principal Investigator: Shahar Frenkel, MD,PhD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Shahar Frenkel, MD, PhD Hadassah Medical Organization

Responsible Party: Hadassah Medical Organization Identifier: NCT01438658     History of Changes
Other Study ID Numbers: 001-HMO-CTIL
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by Hadassah Medical Organization:
uveal melanoma
metastatic uveal melanoma

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases