RetinoblastomaNCT03764930
Attention to Retinoblastoma Diagnosed in the Trauma Setting
An observational study of Retinoblastoma and Wounds and Injury, run by Sun Yat-sen University at 1 site in China.
Trial summary
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma. Read more about this study
- Who is it for?
- Ages 1 month to 80 years
- Conditions the study is for
- Retinoblastoma, Wounds and Injury
- What is being tested?
- Unsuspected Retinoblastoma
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 month to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Those children who experienced accidental ocular trauma with or without brain involvement before diagnosis of unsuspected RB was studied.
Who may be able to join
- The consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018.
Who cannot join
- The patients who didn't have undergone trauma before diagnosis of RB.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
Read the detailed description
Retrospective study of the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma and to alert ophthalmologists to the possibility of RB in children presenting with or without trauma-related symptoms and signs.
- Conditions
- Retinoblastoma, Wounds and Injury
- Being tested
- Unsuspected Retinoblastoma
- Medical subject headings
- Retinoblastoma, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsuspected RetinoblastomaOther
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Status
Outcome at last follow-up
Measured: between January 2013 and August 2018
Secondary outcomes (2)
Trauma incidence of RB patients
We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of trauma among RB patients.
Measured: between January 2013 and August 2018
RB incidence of pre-school patients with trauma history
We reviewed the computerized diagnostic records of consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018. The charts of those patients who had undergone trauma before diagnosis of RB were selected. In addition, we identified the preschool-aged children (age 0-6 years) who underwent surgical treatment for ocular trauma at our hospital during the corresponding period. Then, we calculated the incidence of RB among pre-school patients with trauma history.
Measured: between January 2013 and August 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2013
- Primary completion1 Aug 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huasheng Yang, Sun Yat-sen University
- Investigators
- Huasheng Yang, MD,PhD, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764930
- Sponsor's protocol ID
- yanghs201812
- Status last verified
- Dec 2018
- First submitted
- 1 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attention to Retinoblastoma Diagnosed in the Trauma Setting
- ClinicalTrials.gov ID
- NCT03764930
- Acronym / sponsor ID
- yanghs201812
- Conditions
- Retinoblastoma, Wounds and Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Dec 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.
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
Detailed description
Retrospective study of the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma and to alert ophthalmologists to the possibility of RB in children presenting with or without trauma-related symptoms and signs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Those children who experienced accidental ocular trauma with or without brain involvement before diagnosis of unsuspected RB was studied.
Key inclusion criteria (1 listed)
- The consecutive patients with RB managed at the ocular oncology service of Zhongshan Ophthalmic Center, Sun Yat-sen University, between January 2013 and August 2018.
Key exclusion criteria (1 listed)
- The patients who didn't have undergone trauma before diagnosis of RB.
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 |
|---|---|---|
| Unsuspected RetinoblastomaTo study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma. | Other | – |
Primary outcome
Survival Status
Time frame: between January 2013 and August 2018
Outcome at last follow-up
2 secondary outcomes
Trauma incidence of RB patients
Time frame: between January 2013 and August 2018
RB incidence of pre-school patients with trauma history
Time frame: between January 2013 and August 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Huasheng Yang, MD,PhD study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinoblastoma and Wounds and Injury, run by Sun Yat-sen University at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival Status (time frame: between January 2013 and August 2018). 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 5 Dec 2018.