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NCT Number: NCT01438658

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center

Jerusalem, 91120, Israel

Location status: Recruiting

Location contact

Shahar Frenkel, MD, PhD

CONTACT

[email protected]

+972-2-6776579

Shahar Frenkel, MD,PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of uveal melanoma

Exclusion criteria

  • refusal to participate in the study

Treatment and study plan

Primary outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shahar Frenkel, MD, PhD

CONTACT

[email protected]

+972-2-6776579

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Acronym: UM

Important dates

Study start
2011
Primary completion
2040
Study completion
2040
First posted
Sep 22, 2011
Registry last updated
Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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