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

NCT01438658 | Recruiting

• 1 other identifier: 001-HMO-CTIL
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveal Melanoma

Keywords

uveal melanoma; metastatic uveal melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All

A cohort of all the patients.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with uveal melanoma being treated at our center

You may qualify if:

• diagnosis of uveal melanoma

You may not qualify if:

• refusal to participate in the study

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Specialized Ocular Oncology Service, Hadassah-Hebrew-University Medical Center

Jerusalem, 91120, Israel

RECRUITING

Related 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.

  PMID: 19429579 BACKGROUND

• 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.

  PMID: 19329272 BACKGROUND

• 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.

  PMID: 19270465 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

sera from patients

MeSH Terms

Conditions

Uveal Melanoma

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Shahar Frenkel, MD, PhD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahar Frenkel, MD, PhD

CONTACT

+972-2-6776579; shahar@hadassah.org.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 22, 2011
• Study Start: September 1, 2011
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: September 28, 2011

Record last verified: 2011-09

Locations

IL (1)