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

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ClinicalTrials.gov Identifier: NCT03026998
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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).

Condition or disease Intervention/treatment Phase
Hereditary Retinoblastoma Procedure: MRI Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
MRI Procedure: MRI
MRI will be performed each year during 10 years.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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 ]
  4. 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.

  5. Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI. [ Time Frame: Up to 10 years ]
  6. Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI [ Time Frame: Up to 10 years ]
  7. Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI [ Time Frame: Up to 10 years ]
  8. Measure of sensibility of MRI to detect second primary cancer [ Time Frame: Up to 10 years ]
  9. Measure of specificity of MRI to detect second primary cancer [ Time Frame: Up to 10 years ]
  10. Collection of secondary tumors for future research purpose. [ Time Frame: up to 10 years ]


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Ages Eligible for Study:   7 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 between 7 and 35 years
  • 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

Information from the National Library of Medicine

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


Contacts
Contact: Anne JOCHEM anne.jochem@curie.fr

Locations
France
Institut Curie Recruiting
Paris, France, 75005
Contact: HERVE BRISSE, MD       herve.brisse@curie.fr   
Principal Investigator: Hervé BRISSE, MD         
Sponsors and Collaborators
Institut Curie
Investigators
Principal Investigator: Hervé BRISSE, MD NSTITUT CURIE

Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT03026998     History of Changes
Other Study ID Numbers: IC 2015-14
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Institut Curie:
hereditary retinoblastoma,
External beam radiation therapy (EBRT)

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Second Primary
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases