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Spots Global Cancer Trial Database for SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

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Trial Identification

Brief Title: SPT Screening in Irradiated Hereditary Retinoblastoma Survivors

Official Title: Multicenter Implementation of MR Imaging Studies in Irradiated Hereditary Retinoblastoma Survivors for Assessment of the Value of Craniofacial MRI Screening for Early Detection of Second Craniofacial Primary Tumors and to Enhance Survival

Study ID: NCT02329002

Conditions

Retinoblastoma

Study Description

Brief Summary: Rationale: Hereditary retinoblastoma survivors have an increased risk to develop second primary tumors (SPT) at a later age (with the highest risk in their teens), especially when they have been irradiated for retinoblastoma. The investigators hypothesize that regular screening with magnetic resonance imaging (MRI) could lead to early detection of SPTs leading to improved survival. Objective: To evaluate the potential benefit of craniofacial MRI screening for early detection subclinical secondary cancers in patients previously irradiated for hereditary retinoblastoma. Study design: Prospective multicenter non-invasive screening study. The total study duration will be four years of screening plus five years of follow-up. Study population: Irradiated hereditary retinoblastoma patients 8-18 years old Main study parameters/endpoints: To evaluate the ability of craniofacial MRI for early detection of SPTs, the investigators will determine the sensitivity and specificity of MRI at detecting SPTs in irradiated hereditary retinoblastoma patients. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Included patients will undergo yearly craniofacial MRI for a period of 4 years. They will also be asked to fill out a psychological burden assessment form each visit. A potential risk of screening might be associated anticipatory anxiety, but screening also could be reassuring for patients and their parents; the investigators are not sure which will outweigh. False-positive results from MRI screening could lead to unnecessary further diagnostics leading to possible added anxiety and diagnostics (e.g., biopsies). However, this group of patients have a high risk of developing SPTs, with poor 5-year survival statistics. Early detection and therefore treatment of earlier stage (smaller) tumors, might therefore increase survival of this patient group.

Detailed Description:

Eligibility

Minimum Age: 8 Years

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

VU University Medical Center, Amsterdam, Noord-Holland, Netherlands

Contact Details

Name: Jonas A Castelijns, PhD

Affiliation: Amsterdam UMC, location VUmc

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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