Clinical trial · Observational
Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers
Carcinogen Metabolism, DNA Repair, Parental Exposures and Retinoblastoma
NCT00690469CI-TRIAL-00041040completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This laboratory study is looking at genetic mutations and environmental exposure in young patients with retinoblastoma and in their parents and young healthy unrelated volunteers. Gathering information about gene mutations and environmental exposure may help doctors learn more about the causes of retinoblastoma in young patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extraocular Retinoblastoma | Extraocular Retinoblastoma | ONTOLOGY_EXACT | 0.90 |
| Intraocular Retinoblastoma | Intraocular Retinoblastoma | ONTOLOGY_EXACT | 0.90 |
| Recurrent Retinoblastoma | Retinoblastoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biomarker analysis)
- description
- Participants undergo a structured telephone interview questionnaire. The parental questionnaires collect basic demographic data (including age, race, education, and income), occupational history, medical radiation exposure, diet and supplement use (for the year before pregnancy for father, during pregnancy for mother), tobacco use, and alcohol use. The mothers are also asked about residential pesticides and prior assisted reproductive technology. Controls (parents) provide saliva samples. If a patient is also enrolled on COG-ARET0332, then the patient blood and tumor samples should be submitted. Parents of patients on this protocol should also submit a blood sample. Blood samples from the affected child, and blood and/or sputum samples from the parents may be submitted. Tumor specimens should be submitted if available. For some patients, a RB1 mutation detection assay on DNA derived from peripheral blood is performed. If the mutation is found, the parents? DNA is also screened.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Questionnaire Administration
Primary outcomes (5)
- measure
- Association of the probability of having a child with bilateral retinoblastoma (RB) with the paternal genotype for selected DNA repair and carcinogen metabolizing enzymes (CME) genes
- timeFrame
- Not Provided
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria:
* Cases must meet the following criteria:
* Diagnosed with sporadic retinoblastoma (RB) on or after 07/01/2006
* No familial retinoblastoma
* Have permission of physician to contact the parents
* Diagnosed and/or treated at a Children's Oncology Group (COG) institution or \*Wills Eye Hospital
* Controls must meet 1 of the following criteria:
* Mother of a child with unilateral RB
* Father of a child with bilateral RB
* Age-matched non-blood-related child if possible
* Must reside in the U.S. or Canada
* Must have telephone in the home
* Biological parent speaks English or Spanish
* Concurrent treatment on a therapeutic trial is NOT requiredReferences
Publications (0)
Data not yet available
No reference posted for this study.