Studying Health Outcomes After Treatment in Patients With Retinoblastoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVanderbilt-Ingram Cancer Center

About this trial

This trial studies health outcomes after treatment in patients with retinoblastoma. Gathering health information over time from patients and family members through vision assessments, samples of tissue and saliva, and questionnaires may help doctors learn more about what causes retinoblastoma, identify long-term health outcomes for patients with retinoblastoma, and find out which therapies may be the best for treating retinoblastoma

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Unilateral or bilateral intraocular retinoblastoma

Diagnosis between the ages of 0 - 17.99 years

Diagnosis on or after January 1, 2008

No exclusions based on primary or secondary treatment modalities

Disqualifiers

None

Trial population

Retrospective patients (those treated between 2008 and 2018) identified by each site at the start of the study period and prospective patients (those treated between 2018 and 2023) identified at the time of diagnosis by each site during the study period with unilateral or bilateral intraocular retinoblastoma

Trial design

Design model

Case-control

Time perspective

Other

Treatments tested in this trial

  • Biospecimen collection

    Procedure/Surgery

    Collection of tissue and saliva samples

  • Vision assessment

    Other intervention

    Undergo vision assessment

  • Questionnaire administration

    Other intervention

    Complete questionnaires

  • Quality of life assessment

    Other intervention

    Complete questionnaires

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

900 Participants
are divided into 2 treatment groups
Group A: Retrospective(biospecimens, vision assessment, questionnaires)5 interventions
Group B: Prospective (biospecimens, vision assessment, questionnaires)5 interventions

Trial outcomes

Primary outcomes

1

Incidence of acute toxicity

Time frame
Up to 1 year
2

Estimate malignant neoplasm (SMN) risk .Measured through medical record abstraction,

Time frame
Up to 1 year
3

Assess visual outcomes measured via age appropriate visual acuity testing

Time frame
Up to 1 year
4

Assess psycho-social outcomes utilizing questionnaires: BRIEF

Time frame
Up to 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator