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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01438658
Acronym
UM
Enrollment
250
Registered
2011-09-22
Start date
2011-09-30
Completion date
2040-12-31
Last updated
2011-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma

Keywords

uveal melanoma, 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.

Interventions

None listed

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* diagnosis of uveal melanoma

Exclusion criteria

* refusal to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Significant increase in biomarker level that could be linked with detection of metastases by imagingup to 12 months before diagnosis of metastasesSerum 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.

Countries

Israel

Contacts

Primary ContactShahar Frenkel, MD, PhD
shahar@hadassah.org.il+972-2-6776579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026