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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01438658
First received: September 15, 2011
Last updated: September 27, 2011
Last verified: September 2011

September 15, 2011
September 27, 2011
September 2011
December 2040   (final data collection date for primary outcome measure)
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.
Change in biomarker level that is 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.
Complete list of historical versions of study NCT01438658 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

sera from patients

Non-Probability Sample

All patients diagnosed with uveal melanoma being treated at our center

Uveal Melanoma
Not Provided
All
A cohort of all the patients.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2040
December 2040   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of uveal melanoma

Exclusion Criteria:

  • refusal to participate in the study
Both
Not Provided
No
Contact: Shahar Frenkel, MD, PhD +972-2-6776579 shahar@hadassah.org.il
Israel
 
NCT01438658
001-HMO-CTIL
No
Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
Principal Investigator: Shahar Frenkel, MD, PhD Hadassah Medical Organization
Hadassah Medical Organization
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP