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Quality of Life in Children Cured of Retinoblastoma

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ClinicalTrials.gov Identifier: NCT00278031
Recruitment Status : Recruiting
First Posted : January 18, 2006
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.

Condition or disease

Detailed Description:

Retinoblastoma is the most common eye tumor of children. It can present in one eye (unilateral) or in both eyes (bilateral). The bilateral form is always hereditary.

Retinoblastoma is a highly curable tumor. Using a combination of surgery, chemotherapy, radiation and local treatment modalities to the eye, over 98% of patients are cured. This means that most children diagnosed with retinoblastoma will become long-term survivors.

The use of surgery (taking out one eye), chemotherapy, and radiation may be associated with long term side-effects, some of which may have significant impact on the quality of life of the child. In addition, in case where the disease is hereditary, additional psychological issues arise.

The aim of our study is to assess, in a comprehensive and standardized fashion, the long term quality of life in children who were treated for retinoblastoma, and who are currently alive and well.

The assessment will include the use of questionnaires that assess quality of life, as well as participation in age-appropriate activities.

Each child, and his/her parent, will be interviewed and the questionnaires completed. The process will take about one hour for each child. No risk or discomfort to the child is involved.

Study Design

Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Quality of Life in Children Cured of Retinoblastoma
Study Start Date : March 2006
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: Baseline and 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Long term survivors of childhood retinoblastoma

Inclusion Criteria:

  • Past treatment for retinoblastoma
Contacts and Locations

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): NCT00278031

Contact: Michael Weintraub, MD 972-2-6777408 michaelw@hadassah.org.il

Hadassah Medical Organization, Jerusalem, Israel Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Michael Weintraub, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Israel Cancer Association
Principal Investigator: Michael Weintraub, MD Hadassah Medical Organization
More Information

Responsible Party: Michael Weintraub, DIrector, Pediatric Hematology Oncology, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00278031     History of Changes
Other Study ID Numbers: qolrb-HMO-CTIL
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Michael Weintraub, Hadassah Medical Organization:
Quality of life

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