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

NCT00952939 | Completed DMC

• 3 other identifiers: CASE5608P30CA043703CASE 5608-CC666
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Melanoma

Keywords

ciliary body and choroid melanoma, small size; iris melanoma; intraocular melanoma; ciliary body and choroid melanoma, medium/large size

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 years

Secondary Outcomes (3)

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

  2 years

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

  2 yrs

• distribution of particular markers at specific timepoints

  at baseline, multiple time points up to 2 years

Interventions

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.

Also known as: Hospital Anxiety and Depression Scale (HADS), Decision Regret Scale, The MINI (a structured psychiatric interview)

Eligibility Criteria

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

Study Population

Primary Care Clinic

You may qualify if:

• 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

You may not qualify if:

• Patients with metastasis
• Patients under the age of 18

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

In Situ Hybridization, Fluorescence; Biopsy, Fine-Needle; Surveys and Questionnaires; 4-amino-4'-hydroxylaminodiphenylsulfone

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

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Biopsy, Needle; Biopsy; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arun D. Singh, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: February 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

US (1)