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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01558349 |
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Date of registration:
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17/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Circulating Tumor Cells and Melanoma: Comparing the EPISPOT and CellSearch Techniques
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Scientific title:
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Circulating Tumor Cells and Melanoma: Comparing the EPISPOT (EPithelial ImmunoSPOT) and CellSearch Techniques |
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Date of first enrolment:
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June 27, 2013 |
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Target sample size:
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73 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01558349 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Laurent Meunier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Hospitalier Universitaire de Nîmes |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available, within the hours of his/her normally scheduled medical care,
for blood sampling at 8 am and 4 pm on the same day.
Inclusion Criteria for patients:
- Stage 4 melanoma, without other associated neoplasms
Inclusion Criteria for controls:
- Patient without cancer, nor history of cancer
Exclusion Criteria:
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
- The patient has a contra-indication for a treatment used in this study
Exclusion criteria for patients:
- Stage 1 to 3 melanoma, or other types of cancer
Exclusion criteria for controls:
- History of cancer
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Metastatic Melanoma
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Primary Outcome(s)
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Presence/absence of at least 2 CMCs per ml blood, both techniques
[Time Frame: Day 1 at 8 am]
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Secondary Outcome(s)
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CMCs per ml blood, CellSearch
[Time Frame: Day 1 at 8 am]
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delta CMC
[Time Frame: Day 1 at 8 am]
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% delta CMC
[Time Frame: Day 1 at 8 am]
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Presence/absence of KI67 antigen markers
[Time Frame: Day 1 at 8 am]
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CMCs per ml blood, Epispot
[Time Frame: Day 1 at 8 am]
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% cells with S100 protein markers
[Time Frame: Day 1 at 8 am]
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Secondary ID(s)
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LOCAL/2011/LM-05
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2011-A01156-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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