Survivors of Unilateral RetinoblastomaNCT03662776
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
An observational study of Survivors of Unilateral Retinoblastoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Survivors of Unilateral Retinoblastoma
- What is being tested?
- BASC-3 survey and PROMIS survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2018to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.
Who may be able to join
- Ability to speak and understand English or Spanish
- Diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution
- Treatment of retinoblastoma between 2006 or later
- Patients must between the age of 8-17 years old
- At least 1 year since completion of all cancer-directed therapy
- Treatment with enucleation of the affected eye or intra-arterial chemotherapy
Show all 10Show fewer
- Parent of patient:
- Ability to speak and understand English or Spanish
- Ability to confirm that he or she is the parent of a child treated for unilateral retinoblastoma who meets the eligibility criteria listed above
- Ability to provide informed consent
Who cannot join
- Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Texas Children's Hospital (Data Collection)
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.
- Conditions
- Survivors of Unilateral Retinoblastoma
- Being tested
- BASC-3 survey, PROMIS survey
- Keywords
- Quality of Life, physical health, emotional health, 18-397
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BASC-3 surveyBehavioural
A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
PROMIS surveyBehavioural
A comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older.
| Study group | Role | What they receive |
|---|---|---|
| retinoblastoma survivors treated with enucleation | MSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference. Receives: Behavioral: BASC-3 survey; Behavioral: PROMIS survey | |
| retinoblastoma survivors treated with intra-arteria chemo | MSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference. Receives: Behavioral: BASC-3 survey; Behavioral: PROMIS survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
social-emotional health
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3;as measured by the BASC-3) Surveys have been normed on a representative sample that closely matches United States census population characteristics; T scores and percentiles in relation to general norms are calculated for each scale. The BASC-3 uses a T score metric where 50 is the mean for the population norm and the standard deviation is 10.
Measured: 2 years
behavioral health
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3; The following four T Scores will be analyzed for these BASC-3 summary scores (1) Externalizing Problems, (2) Internalizing Problems, (3) Behavior Symptoms Index and (4) Adaptive Skills. The "at-risk" category applies to any individual who scores 2 SD above the mean of 50, while "clinically significant" risk refers to those who score 3 SD above the mean. Additional scores are also provided which may be used to identify risk for more specific behavioral or emotional areas of concern.
Measured: 2 year
compare HRQoL
as measured by the Patient Reported Outcomes Measurement Information System (PROMIS®) PROMIS measures use a T-score metric where 50 is the mean for the reference population and 10 is the standard deviation of that population. Higher scores correspond to a higher degree of symptom burden (for those items measuring symptoms) or a higher level of functioning (for physical functioning items)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start31 Aug 2018
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Survivors of Unilateral RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Cimini, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662776
- Sponsor's protocol ID
- 18-397
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2018
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
- ClinicalTrials.gov ID
- NCT03662776
- Acronym / sponsor ID
- 18-397
- Conditions
- Survivors of Unilateral Retinoblastoma
- Keywords
- Quality of Life, physical health, emotional health, 18-397
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out about the quality of life and health in patients who had retinoblastoma in one eye (unilateral retinoblastoma), who either received treatment with chemotherapy injected directly into an artery leading to the eye (intra-arterial chemotherapy) or removal of the eye (enucleation). By quality of life, the investigators mean how the participants are feeling about being satisfied with things in their life, including, physical health, emotional health, and their ability to carry out daily activities. The investigators want to see if either treatment option would affect quality of life differently. The investigators hope that this information will help us provide better care to future children with retinoblastoma and better follow-up care for survivors of retinoblastoma.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retinoblastoma survivors treated with enucleation | – | Behavioral: BASC-3 survey, Behavioral: PROMIS surveyMSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference. |
| retinoblastoma survivors treated with intra-arteria chemo | – | Behavioral: BASC-3 survey, Behavioral: PROMIS surveyMSK will contact all families of 1-year survivors of unilateral retinoblastoma treated with enucleation or intra-arterial chemotherapy at MSK and TCH between 2006 or later for completion of validated questionnaires integrating the BASC-3 and PROMIS surveys. The survey may be administered in-person during clinic or by mail, based upon participant preference. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Eligible survivors of unilateral retinoblastoma will be identified via the MSK and TCH databases and offered participation in the study.
Key inclusion criteria (10 listed)
- Ability to speak and understand English or Spanish
- Diagnosis of unilateral retinoblastoma at any age, confirmed by the enrolling institution
- Treatment of retinoblastoma between 2006 or later
- Patients must between the age of 8-17 years old
- At least 1 year since completion of all cancer-directed therapy
Key exclusion criteria (1 listed)
- Patients, or parents of patients, treated with both enucleation and intra-arterial chemotherapy are not eligible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BASC-3 surveyA comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older. | Behavioural | retinoblastoma survivors treated with enucleation, retinoblastoma survivors treated with intra-arteria chemo |
| PROMIS surveyA comprehensive questionnaire, incorporating the BASC-3 and PROMIS measures, will be administered to parents of participants ages 8-17. The BASC-3 and PROMIS scales each have a parent and child version; these scales will be used to measure the secondary objective of parent and patient concordance rates for all participants ages 8 and older. | Behavioural | retinoblastoma survivors treated with enucleation, retinoblastoma survivors treated with intra-arteria chemo |
Primary outcome
social-emotional health
Time frame: 2 years
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3;as measured by the BASC-3) Surveys have been normed on a representative sample that closely matches United States census population characteristics; T scores and percentiles in relation to general norms are calculated for each scale. The BASC-3 uses a T score metric where 50 is the mean for the population norm and the standard deviation is 10.
behavioral health
Time frame: 2 year
as measured by Behavior Assessment System for Children, 3rd edition, (BASC™-3; The following four T Scores will be analyzed for these BASC-3 summary scores (1) Externalizing Problems, (2) Internalizing Problems, (3) Behavior Symptoms Index and (4) Adaptive Skills. The "at-risk" category applies to any individual who scores 2 SD above the mean of 50, while "clinically significant" risk refers to those who score 3 SD above the mean. Additional scores are also provided which may be used to identify risk for more specific behavioral or emotional areas of concern.
compare HRQoL
Time frame: 2 years
as measured by the Patient Reported Outcomes Measurement Information System (PROMIS®) PROMIS measures use a T-score metric where 50 is the mean for the reference population and 10 is the standard deviation of that population. Higher scores correspond to a higher degree of symptom burden (for those items measuring symptoms) or a higher level of functioning (for physical functioning items)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Cimini, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Survivors of Unilateral Retinoblastoma, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
social-emotional health (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.