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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Institut Curie

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Institut Curie

Dates:
Date Received: January 6, 2017
Date Started: March 19, 2017
Date Completion: January 2032
Last Updated: March 31, 2017
Last Verified: March 2017