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NCT Number: NCT00952939

Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.

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Key information

Conditions

Intraocular Melanoma Eye Diseases Eye Neoplasms Melanoma 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 Uveal Melanoma Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

About this study

OBJECTIVES:

Primary

  • To establish the feasibility of using fine needle aspiration (FNA) and FISH to determine tumor genotype in patients with primary uveal melanoma.

Secondary

  • To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
  • To estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification.
  • To explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E- cadherin).
  • To explore the psychological impact of prognostication in uveal melanoma.

OUTLINE: Patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines.

Trans-scleral fine needle aspiration (FNA) is performed at the time of plaque radiotherapy and ex vivo FNA is performed on enucleation and tumor resection specimens. Tissue samples are analyzed by fluorescence in situ hybridization (FISH). Blood samples are also collected for further analysis.

After completion of study therapy, patients are followed up periodically.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids
  • Patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease
  • Patients must not have received any local or systemic therapy for uveal melanoma
  • All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. A copy of the informed consent document signed by the patient must be given to the patient
  • Patients must have the following pretreatment laboratory findings:
  • Bilirubin (total) </= 1.5 ml/dl
  • AST </= 2 x normal
  • ALT </= 2 x normal
  • Alkaline phosphatase </= 2 x normal

Exclusion criteria

  • Patients with metastasis
  • Patients under the age of 18

Treatment and study plan

fluorescence in situ hybridization

Genetic

At time of surgery

laboratory biomarker analysis

Other

At time of surgery

Fine-Needle Aspiration

Procedure

At time of surgery

therapeutic conventional surgery

Procedure

At time of surgery

questionnaires

Other

The MINI (a structured psychiatric interview) will be administered to all patients that had a pre or post-operative HADS score for suggestive or probable depression or anxiety. A semi-structured interview would be administered to those patients who had some or full decision regret pre-operatively. After completion of the interview, the MINI, a structured psychiatric interview, will be administered.

Other names: Hospital Anxiety and Depression Scale (HADS), Decision Regret Scale, The MINI (a structured psychiatric interview)

Primary outcomes

  1. Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes

    Time frame: 2 years

    DFS will be measured from the date of initial treatment to the date of documented recurrence or death. It will be summarized using the method of Kaplan and Meier.

Secondary outcomes

  1. Number of patients with adverse events to determine ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.

    Time frame: 2 years

    To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.

  2. The rate that sufficient tissue can be obtained by FNA.

    Time frame: 2 yrs

    Determine if sufficient material for FISH analysis can be obtained by transscleral FNA, a diagnostic procedure performed for a variety of clinical indications in patients with eye abnormalities.

  3. distribution of particular markers at specific timepoints

    Time frame: at baseline, multiple time points up to 2 years

    Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Aug 6, 2009
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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