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
  Purpose

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.


Condition Intervention
Intraocular Melanoma
Genetic: fluorescence in situ hybridization
Other: laboratory biomarker analysis
Procedure: fine-needle aspiration
Procedure: therapeutic conventional surgery
Other: Questionnaires

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary Care Clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952939

Locations
United States, Ohio
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Arun D. Singh, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00952939     History of Changes
Other Study ID Numbers: CASE5608, P30CA043703, CASE5608, CASE 5608-CC666
Study First Received: August 5, 2009
Last Updated: January 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
ciliary body and choroid melanoma, small size
iris melanoma
intraocular melanoma
ciliary body and choroid melanoma, medium/large size

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on September 16, 2014