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

Uveal Melanoma Clinical Trial

— UM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01438658
• Other study ID #: 001-HMO-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 15, 2011
• Last updated: September 27, 2011
• Start date: September 2011
• Est. completion date: December 2040

Study information

• Verified date: September 2011
• Source: Hadassah Medical Organization
• Contact: Shahar Frenkel, MD, PhD
• Phone: +972-2-6776579
• Email: shahar[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of uveal melanoma

Exclusion Criteria:

• refusal to participate in the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Locations

Country	Name	City	State
Israel	Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Frenkel S, Nir I, Hendler K, Lotem M, Eid A, Jurim O, Pe'er J. Long-term survival of uveal melanoma patients after surgery for liver metastases. Br J Ophthalmol. 2009 Aug;93(8):1042-6. doi: 10.1136/bjo.2008.153684. Epub 2009 May 7. — View Citation

Haritoglou I, Wolf A, Maier T, Haritoglou C, Hein R, Schaller UC. Osteopontin and 'melanoma inhibitory activity': comparison of two serological tumor markers in metastatic uveal melanoma patients. Ophthalmologica. 2009;223(4):239-43. doi: 10.1159/000206139. Epub 2009 Mar 6. — View Citation

Mariani P, Piperno-Neumann S, Servois V, Berry MG, Dorval T, Plancher C, Couturier J, Levy-Gabriel C, Lumbroso-Le Rouic L, Desjardins L, Salmon RJ. Surgical management of liver metastases from uveal melanoma: 16 years' experience at the Institut Curie. Eur J Surg Oncol. 2009 Nov;35(11):1192-7. doi: 10.1016/j.ejso.2009.02.016. Epub 2009 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant increase in biomarker level that could be linked with detection of metastases by imaging	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.	up to 12 months before diagnosis of metastases	No