PROTOCOL FOR THE DIAGNOSIS AND THERAPY OF INTRAOCULAR RETINOBLASTOMA
- Conditions
- Intraocular retinoblastomaTherapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 20.0Level: PTClassification code 10038916Term: RetinoblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2019-000742-35-IT
- Lead Sponsor
- ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 44
• Clinical diagnosis of single or bilateral intraocular Retinoblastoma (stage 0 according to International Retinoblastoma Staging System-IRSS)
• Patients <16 years old
• No previous chemo or radiotherapy treatment
. Ophthalmological evaluation with Fundus Cam Overview and classification of intraocular lesions according to International Intraocular Retinolastoma Classification-IIRC - Performance status: Lansky = 50
• Written informed consent signed by parents or legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patients = 16 years old
• Patients not evaluated with panormic Fundus-Cam at diagnosis
• Patients who have received prior chemo or radiotherapy treatments
• Ongoing pregnancy or breastfeeding
• Hypersensitivity to any component of the study drugs
• Vaccination with live and attenuated virus
• Subjects with neuromuscular disorders
• Presence of exclusion criteria for conservative treatment
• Absence of eligibility criteria for the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method