Back to resultsMRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH) (DepiSCARRH)
Primary Purpose
Hereditary Retinoblastoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Hereditary Retinoblastoma focused on measuring hereditary retinoblastoma,, External beam radiation therapy (EBRT)
Eligibility Criteria
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
Sites / Locations
- Institut CurieRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program
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.
Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
Measure of sensibility of MRI to detect second primary cancer
Measure of specificity of MRI to detect second primary cancer
Collection of secondary tumors for future research purpose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03026998
Brief Title
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)
Acronym
DepiSCARRH
Official Title
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 19, 2017 (Actual)
Primary Completion Date
March 2034 (Anticipated)
Study Completion Date
March 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Retinoblastoma
Keywords
hereditary retinoblastoma,, External beam radiation therapy (EBRT)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
MRI will be performed each year during 10 years.
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
Up to 10 years
Secondary Outcome Measure Information:
Title
Assess the visual prognosis of patients with second primary cancer depicted by MRI
Description
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.
Time Frame
Up to 10 year
Title
Assess the feasibility of the MR screening program.
Description
Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study.
Time Frame
Up to 10 years
Title
Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program
Time Frame
Up to 10 years
Title
Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.
Description
- Quality of life questionnaires completed by the patient every year (before MRI) during 10 years.
Time Frame
Up to 10 years
Title
Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
Time Frame
Up to 10 years
Title
Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
Time Frame
Up to 10 years
Title
Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
Time Frame
Up to 10 years
Title
Measure of sensibility of MRI to detect second primary cancer
Time Frame
Up to 10 years
Title
Measure of specificity of MRI to detect second primary cancer
Time Frame
Up to 10 years
Title
Collection of secondary tumors for future research purpose.
Time Frame
up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne JOCHEM
Phone
+33 (0) 56 24 56 01
Email
anne.jochem@curie.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé BRISSE, MD
Organizational Affiliation
NSTITUT CURIE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HERVE BRISSE, MD
Email
herve.brisse@curie.fr
First Name & Middle Initial & Last Name & Degree
Hervé BRISSE, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)
We'll reach out to this number within 24 hrs