Intraocular MelanomaNCT00952939
Study of Tumor Samples in Patients Undergoing Radiation Therapy or Surgery For Primary Melanoma of the Eye
An observational study of Intraocular Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Melanoma
- What is being tested?
- fluorescence in situ hybridization, laboratory biomarker analysis and fine-needle aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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
Show all 9Show fewer
- AST </= 2 x normal
- ALT </= 2 x normal
- Alkaline phosphatase </= 2 x normal
Who cannot join
- Patients with metastasis
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, 44195
About this study
Official title: 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.
Read the 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.
- Conditions
- Intraocular Melanoma
- Being tested
- fluorescence in situ hybridization, laboratory biomarker analysis, fine-needle aspiration, therapeutic conventional surgery, Questionnaires
- Keywords
- ciliary body and choroid melanoma, small size, iris melanoma, intraocular melanoma, ciliary body and choroid melanoma, medium/large size
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
At time of surgery
laboratory biomarker analysisOther
At time of surgery
fine-needle aspirationProcedure or surgery
At time of surgery
therapeutic conventional surgeryProcedure or surgery
At time of surgery
QuestionnairesOther
Also called Hospital Anxiety and Depression Scale (HADS), Decision Regret Scale, The MINI (a structured psychiatric interview)
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
To characterize ophthalmic complication rate of FNA for FISH analysis in patients undergoing plaque radiotherapy.
Measured: 2 years
The rate that sufficient tissue can be obtained by FNA.
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.
Measured: 2 yrs
distribution of particular markers at specific timepoints
Plasma will be analyzed for circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble E-cadherin.
Measured: at baseline, multiple time points up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular MelanomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arun D. Singh, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952939
- Sponsor's protocol ID
- CASE5608
- Other IDs
- P30CA043703, CASE5608, CASE 5608-CC666
- Status last verified
- Jan 2015
- First submitted
- 5 Aug 2009
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostication of Uveal Melanoma by Fine Needle Aspiration (FNA) and Fluorescence in Situ Hybridization (FlSH)
- ClinicalTrials.gov ID
- NCT00952939
- Acronym / sponsor ID
- CASE5608
- Conditions
- Intraocular Melanoma
- Keywords
- ciliary body and choroid melanoma, small size, iris melanoma, intraocular melanoma, ciliary body and choroid melanoma, medium/large size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (2 listed)
- Patients with metastasis
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescence in situ hybridizationAt time of surgery | Genetic | – |
| laboratory biomarker analysisAt time of surgery | Other | – |
| fine-needle aspirationAt time of surgery | Procedure or surgery | – |
| therapeutic conventional surgeryAt time of surgery | Procedure or surgery | – |
| QuestionnairesAlso: Hospital Anxiety and Depression Scale (HADS), Decision Regret Scale, The MINI (a structured psychiatric interview)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 | – |
Primary outcome
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.
3 secondary outcomes
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
The rate that sufficient tissue can be obtained by FNA.
Time frame: 2 yrs
distribution of particular markers at specific timepoints
Time frame: at baseline, multiple time points up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun D. Singh, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Melanoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.