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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.
Verified September 2011 by Hadassah Medical Organization
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438658
First Posted: September 22, 2011
Last Update Posted: September 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 15, 2011
First Posted: September 22, 2011
Last Update Posted: September 28, 2011
Last Verified: September 2011

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