CompletedNot Applicable

Genetic Mutations and Environmental Exposure in Young Patients With Retinoblastoma and in Their Parents and Young Healthy Unrelated Volunteers

United States, Canada, Puerto Rico234 participantsStarted 2008-06-02

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 required

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Probability that mothers of unilateral RB cases are more likely to have specific DNA-repair gene variants than the mothers of the control group

Timeframe: Not Provided

Significant effect of specific DNA repair and CME genotypes on the risk of unilateral RB

Timeframe: Not Provided

Probability that the bilateral RB1 mutation subtype will vary by DNA repair or CME genotype or preconception exposures of the fathers of bilateral RB cases

Timeframe: Not Provided

Probability that the unilateral RB1 mutation subtype will vary by DNA repair or CME genotype of the mother, of the affected child, and with gestational exposures

Timeframe: Not Provided

Trial details

NCT IDNCT00690469

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2015-09-01

View on ClinicalTrials.gov More Extraocular Retinoblastoma trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Probability that mothers of unilateral RB cases are more likely to have specific DNA-repair gene variants than the mothers of the control group

Timeframe: Not Provided

Significant effect of specific DNA repair and CME genotypes on the risk of unilateral RB

Timeframe: Not Provided

Probability that the bilateral RB1 mutation subtype will vary by DNA repair or CME genotype or preconception exposures of the fathers of bilateral RB cases

Timeframe: Not Provided

Probability that the unilateral RB1 mutation subtype will vary by DNA repair or CME genotype of the mother, of the affected child, and with gestational exposures

Timeframe: Not Provided