MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH) (DepiSCARRH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03026998|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hereditary Retinoblastoma||Procedure: MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||190 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma|
|Actual Study Start Date :||March 19, 2017|
|Estimated Primary Completion Date :||January 2032|
|Estimated Study Completion Date :||January 2032|
MRI will be performed each year during 10 years.
- 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
- Assess the visual prognosis of patients with second primary cancer depicted by MRI [ Time Frame: Up to 10 year ]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. [ Time Frame: Up to 10 years ]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 [ 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 ]- 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. [ 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026998
|Contact: Anne JOCHEMfirstname.lastname@example.org|
|Paris, France, 75005|
|Contact: HERVE BRISSE, MD email@example.com|
|Principal Investigator: Hervé BRISSE, MD|
|Principal Investigator:||Hervé BRISSE, MD||NSTITUT CURIE|