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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
  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

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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
Study Population

All patients diagnosed with uveal melanoma being treated at our center

Criteria

Inclusion Criteria:

  • diagnosis of uveal melanoma

Exclusion Criteria:

  • refusal to participate in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438658

Contacts
Contact: Shahar Frenkel, MD, PhD +972-2-6776579 shahar@hadassah.org.il

Locations
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         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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
Eye Diseases
Eye Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Uveal Diseases

ClinicalTrials.gov processed this record on November 24, 2014