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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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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2016091929875N1 |
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Date of registration:
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2016-10-05 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Using radioactive iodide 125 in uveal melanoma
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Scientific title:
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Evaluation of the efficacy of radioactive iodide 125 made in Iran in uveal melanoma |
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Date of first enrolment:
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2016-09-22 |
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Target sample size:
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15 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/23906 |
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Study type:
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interventional |
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Study design:
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Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.
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Phase:
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2
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Fariba Ghassemi
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Address:
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Farabi Hospital, South Kargar street, Qazvin Square
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 5540 0010 |
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Email:
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ghasemi_f@sina.tums.ac.ir |
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Affiliation:
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Tehran University of Medical Sciences |
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Name:
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Fariba Ghassemi
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Address:
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Farabi Hospital, South Kargar, Qazvin Square
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 5540 0010 |
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Email:
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ghasemi_f@sina.tums.ac.ir |
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Affiliation:
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Tehran University of Medical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria: INCLUSION: All the patients with uveal melanoma that are not the candidates for ruthenium plaques and un-acception of the enucleation by the patient.
Exclusion: Unwillingness of the patient for continuing the study, pregnancy and nursing.
Exclusion criteria:
Age minimum:
18 years
Age maximum:
90 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Choroid
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Uveal melanoma.
Choroid
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Intervention(s)
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Treatment - Devices
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This intervention will be undertaken as implantation of Iodide radioactive plaque under the ocular tumor on sclera, for a measured time, according to the thickness of the tumor.
After this period of time, the plaque will be removed and the patient will be followed..
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This intervention will be undertaken as implantation of Iodide radioactive plaque under the ocular tumor on sclera, for a measured time, according to the thickness of the tumor.
After this period of time, the plaque will be removed and the patient will be followed.
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Primary Outcome(s)
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Decrease in the thickness of tumor. Timepoint: At 4 months. Method of measurement: ultrasound and clinical examination.
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Source(s) of Monetary Support
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Tehran University of Medical Sciences
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Ethics review
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Status: Approved
Approval date:
Contact:
Tehran University of Medical Sciences ethics committee
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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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