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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00952939
First received: August 5, 2009
Last updated: January 24, 2014
Last verified: January 2014

August 5, 2009
January 24, 2014
March 2009
September 2012   (final data collection date for primary outcome measure)
Number of patients that have Disease Free Survival (DFS) with primary uveal melanoma with and without high-risk genotypes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.
Feasibility of using FNA and FISH to determine tumor genotype [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952939 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
  • The rate that sufficient tissue can be obtained by FNA. [ Time Frame: 2 yrs ] [ Designated as safety issue: No ]
    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.
  • distribution of particular markers at specific timepoints [ Time Frame: at baseline, multiple time points up to 2 years ] [ Designated as safety issue: No ]
    Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.
  • Ophthalmic complication rate of FNA for FISH analysis [ Designated as safety issue: No ]
  • Disease-free survival with and without tumor monosomy 3 and/or 8q amplification [ Designated as safety issue: No ]
  • Relationship between biomarkers and the presence of monosomy 3 and/or 8q amplification [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary Care Clinic

Intraocular Melanoma
  • Genetic: fluorescence in situ hybridization
    At time of surgery
    Other Name: fluorescence in situ hybridization
  • Other: laboratory biomarker analysis
    At time of surgery
    Other Name: laboratory biomarker analysis
  • Procedure: fine-needle aspiration
    At time of surgery
    Other Name: fine-needle aspiration
  • Procedure: therapeutic conventional surgery
    At time of surgery
    Other Name: therapeutic conventional surgery
  • Other: Questionnaires
    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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
May 2014
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952939
CASE5608, P30CA043703, CASE5608, CASE 5608-CC666
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Arun D. Singh, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP