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

NCT ID: NCT01438658

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Uveal Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All

A cohort of all the patients.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosis of uveal melanoma

Exclusion Criteria

* refusal to participate in the study
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shahar Frenkel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Shahar Frenkel, MD, PhD

Role: CONTACT

+972-2-6776579

Facility Contacts

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Shahar Frenkel, MD, PhD

Role: primary

+972-2-6776579

References

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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.

Reference Type BACKGROUND
PMID: 19429579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19329272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19270465 (View on PubMed)

Other Identifiers

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001-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id