Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma (UM)
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Purpose
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 |
|---|
|
Uveal Melanoma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Assessing the Clinical Effectiveness of Serum Biomarkers in the Diagnosis of Metastatic Uveal Melanoma |
- 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 ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 250 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2040 |
| Estimated Primary Completion Date: | December 2040 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
All
A cohort of all the patients.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: Shahar Frenkel, MD, PhD | +972-2-6776579 | shahar@hadassah.org.il |
| Israel | |
| Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center | Recruiting |
| Jerusalem, Israel, 91120 | |
| Contact: Shahar Frenkel, MD, PhD +972-2-6776579 shahar@hadassah.org.il | |
| Principal Investigator: Shahar Frenkel, MD,PhD | |
| Principal Investigator: | Shahar Frenkel, MD, PhD | Hadassah Medical Organization |
More Information
Publications:
| Responsible Party: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT01438658 History of Changes |
| Other Study ID Numbers: | 001-HMO-CTIL |
| Study First Received: | September 15, 2011 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Hadassah Medical Organization:
|
uveal melanoma metastatic uveal melanoma |
Additional relevant MeSH terms:
|
Melanoma Uveal Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Eye Neoplasms Neoplasms by Site Eye Diseases Uveal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013