Hereditary RetinoblastomaDepiSCARRHNCT03026998
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)
A study testing MRI in people with Hereditary Retinoblastoma, run by Institut Curie at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Hereditary Retinoblastoma
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2017to Mar 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Hereditary Retinoblastoma
- Being tested
- MRI
- Keywords
- hereditary retinoblastoma,, External beam radiation therapy (EBRT)
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI will be performed each year during 10 years.
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | Not described Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 10 years
Secondary outcomes (10)
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.
Measured: 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.
Measured: Up to 10 years
Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program
Measured: 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.
Measured: Up to 10 years
Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
Measured: Up to 10 years
Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
Measured: Up to 10 years
Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
Measured: Up to 10 years
Measure of sensibility of MRI to detect second primary cancer
Measured: Up to 10 years
Measure of specificity of MRI to detect second primary cancer
Measured: Up to 10 years
Collection of secondary tumors for future research purpose.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start19 Mar 2017
- Primary completionMar 2034 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hervé BRISSE, MD, Principal investigator, NSTITUT CURIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026998
- Sponsor's protocol ID
- IC 2015-14
- Acronym
- DepiSCARRH
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2017
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma
- ClinicalTrials.gov ID
- NCT03026998
- Acronym / sponsor ID
- DepiSCARRH / IC 2015-14
- Conditions
- Hereditary Retinoblastoma
- Keywords
- hereditary retinoblastoma,, External beam radiation therapy (EBRT)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 19 Mar 2017 (actual)
- Primary completion
- Mar 2034 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Procedure: MRI |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI will be performed each year during 10 years. | Procedure or surgery | MRI |
Primary outcome
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).
Time frame: Up to 10 years
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
10 secondary outcomes
Assess the visual prognosis of patients with second primary cancer depicted by MRI
Time frame: Up to 10 year
Assess the feasibility of the MR screening program.
Time frame: Up to 10 years
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
Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.
Time frame: Up to 10 years
Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
Time frame: Up to 10 years
Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
Time frame: Up to 10 years
Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
Time frame: Up to 10 years
Measure of sensibility of MRI to detect second primary cancer
Time frame: Up to 10 years
Measure of specificity of MRI to detect second primary cancer
Time frame: Up to 10 years
Collection of secondary tumors for future research purpose.
Time frame: up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé BRISSE, MD principal investigator
NSTITUT CURIE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Hereditary Retinoblastoma, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.