DIAGNOSTIC AND THERAPEUTIC STUDY FOR NEWLY DIAGNOSED RETINOBLASTOMA PATIENTS RTB AIEOP 012

Phase 1

• Conditions: ewly diagnosed retinoblastoma patients; MedDRA version: 14.1Level: PTClassification code 10038916Term: RetinoblastomaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-006109-85-IT
• Lead Sponsor: A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age <18 anni • Retinoblastoma Diagnosis • None previous chemiotherapy or radiotherapy treatment • Panoramic Fundus Cam evaluation • Staging according to Classification System Intraocular Retinoblastoma e International Retinoblastoma Staging System • Performance status: Karnofsky = 60 o Lansky = 50. • Informed Consent signed by the parents o a legal guardian
Are the trial subjects under 18? yes
Number of subjects for this age range: 122
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

Exclusion Criteria

-Concomitant radiotherapy or chemotherapy or immunoomodulation -pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified