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The purpose of this study is to assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).
Patients with hereditary retinoblastoma treated during infancy by external beam radiation therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high. The aim of this study is to depict by MRI secondary tumors as early as possible, before the occurrence of clinical symptoms. Affected patients will be further managed in a national expert center with dedicated diagnostic and treatment procedures. However, the benefit of such management has to be assessed in terms of prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Procedure | MRI will be performed each year during 10 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT). | Rate of patients with R0-resection quality (versus R1 or R2) among patients with second primary cancer depicted by MRI, with comparison to historical series | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the visual prognosis of patients with second primary cancer depicted by MRI | Measure of residual visual functions before and after local treatment of the second primary cancer in patients depicted by MRI compared to that patients who the second primary cancer was depicted by clinical symptoms. | Up to 10 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hervé BRISSE, MD | NSTITUT CURIE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Curie | Paris | 75005 | France |
Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
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| Assess the feasibility of the MR screening program. |
Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study. |
| Up to 10 years |
| Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program | Up to 10 years |
| Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires. | - Quality of life questionnaires completed by the patient every year (before MRI) during 10 years. | Up to 10 years |
| Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI. | Up to 10 years |
| Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI | Up to 10 years |
| Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI | Up to 10 years |
| Measure of sensibility of MRI to detect second primary cancer | Up to 10 years |
| Measure of specificity of MRI to detect second primary cancer | Up to 10 years |
| Collection of secondary tumors for future research purpose. | up to 10 years |
| ID | Term |
|---|---|
| D012175 | Retinoblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
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