Intraocular MelanomaNCT00897624
Bone Marrow and Blood Samples From Patients With Metastatic Choroid Melanoma
An observational study of Intraocular Melanoma, run by Institut Curie.
Trial summary
RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease. PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma. 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?
- gene expression analysis, reverse transcriptase-polymerase chain reaction and laboratory biomarker analysis
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to May 2011
- 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
DISEASE CHARACTERISTICS:
- Choroid melanoma
- Metastatic disease
- Planning to undergo general anesthesia
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- No contraindications to the collection of a bone marrow sample
- No patient deprived of liberty or under trusteeship (including guardianship)
- No social or psychological situations that preclude the ability to give consent
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma
RATIONALE: Studying samples of bone marrow and blood from patients with cancer may help doctors find out the extent of disease.
PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma.
OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.
- Conditions
- Intraocular Melanoma
- Being tested
- gene expression analysis, reverse transcriptase-polymerase chain reaction, laboratory biomarker analysis
- Keywords
- metastatic intraocular melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small 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.
gene expression analysisGenetic
reverse transcriptase-polymerase chain reactionGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2011
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.
- 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
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Investigators
- Pierre T. Dorval, MD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897624
- Sponsor's protocol ID
- CDR0000633500
- Other IDs
- CLCC-IC-Micrometa-Melanome, CLCC-IC-2007-03, INCA-RECF0631
- Status last verified
- May 2011
- First submitted
- 9 May 2009
- Last updated
- 13 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Detection of Tumor Cells in Bone Marrow and Blood in Patients With Choroid Melanoma
- ClinicalTrials.gov ID
- NCT00897624
- Acronym / sponsor ID
- CDR0000633500
- Conditions
- Intraocular Melanoma
- Keywords
- metastatic intraocular melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2011 (actual)
- First posted
- 12 May 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 bone marrow and blood from patients with cancer may help doctors find out the extent of disease.
PURPOSE: This research study is collecting bone marrow and blood samples from patients with metastatic choroid melanoma.
Detailed description
OBJECTIVES:
Primary
- Develop and validate a method of detecting tumor cells in the bone marrow and blood in patients with metastatic choroid melanoma.
OUTLINE: While patients are under general anesthesia for standard treatment of their disease, samples of bone marrow from the iliac crest and blood are collected. Samples are analyzed for the expression of tyrosinase and Melan-a via RT-PCR.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells
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 13 May 2011.
Related trials for Intraocular Melanoma
RecruitingObservational study
High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes
Uveal Melanoma, High-risk Uveal Melanoma
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingPhase 2
HS-IT101 Injection Versus Chemotherapy in the Treatment of Advanced Melanoma（FASTIL-Mela02）
Melanoma (Excluding Uveal Melanoma)
Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Uveal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
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.
Pierre T. Dorval, MD principal investigator
Institut Curie
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Melanoma, run by Institut Curie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Detection of micro-metastatic cells in 20 x 10^6 nucleated cells. 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 13 May 2011.