MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH) (DepiSCARRH)

MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma

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).

Study Overview

• Status: Recruiting
• Conditions: Hereditary Retinoblastoma
• Intervention / Treatment: Procedure: MRI

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 167
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne JOCHEM; Phone Number: +33 (0) 56 24 56 01; Email: anne.jochem@curie.fr

Study Locations

• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Contact: HERVE BRISSE, MD; Email: herve.brisse@curie.fr
    • Principal Investigator: Hervé BRISSE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Personal history of hereditary retinoblastoma (i.e., familial history of retinoblastoma, or bilateral retinoblastoma, or unilateral multifocal retinoblastoma, or identified germline RB1 mutation or 13q deletion)
• External beam radiation therapy (EBRT) used for retinoblastoma treatment
• Age at inclusion greater or equal to 7 years old.
• Time period between the end of EBRT and inclusion date of 5 years or more
• Written informed consent signed by patient (or legal representative)

Exclusion Criteria:

• Personal history of non-familial unilateral unifocal retinoblastoma without RB1 germline mutation.
• Personal history of second primary neoplasm occurring within radiation fields
• Contraindication for MRI (pacemaker, intraocular metallic foreign body, defibrillators or other implanted electronic devices, intracranial ferro-magnetic clips) or associated conditions preventing from MR examination (intraocular prostheses and implants are not a contraindication for MRI; orthodontic metallic devices are not a contraindication but might decrease the image quality and should be removed, if possible)
• Patients unable to comply with follow-up study requirements, for any geographical, social or psychological reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MRI	Procedure: MRI; MRI will be performed each year during 10 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: Hervé BRISSE, MD, NSTITUT CURIE

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2017
• Primary Completion (Estimated): March 1, 2034
• Study Completion (Estimated): March 1, 2034

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimated): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: hereditary retinoblastoma,; External beam radiation therapy (EBRT)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Eye Diseases; Retinal Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Eye Diseases, Hereditary; Eye Neoplasms; Retinal Neoplasms; Retinoblastoma; Neoplasms, Second Primary
• Other Study ID Numbers: IC 2015-14 DepISCARRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: 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).
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No