- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764930
Attention to Retinoblastoma Diagnosed in the Trauma Setting
December 4, 2018 updated by: Huasheng Yang, Sun Yat-sen University
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
10
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Zhongshan Ophthalmic Center, Sun Yat-sen University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 80 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Those children who experienced accidental ocular trauma with or without brain involvement before diagnosis of unsuspected RB was studied.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The patients who didn't have undergone trauma before diagnosis of RB.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Status
Time Frame: between January 2013 and August 2018
|
Outcome at last follow-up
|
between January 2013 and August 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trauma incidence of RB patients
Time Frame: between January 2013 and August 2018
|
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.
|
between January 2013 and August 2018
|
RB incidence of pre-school patients with trauma history
Time Frame: between January 2013 and August 2018
|
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.
|
between January 2013 and August 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Huasheng Yang, MD,PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2013
Primary Completion (Actual)
August 1, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
December 1, 2018
First Submitted That Met QC Criteria
December 4, 2018
First Posted (Actual)
December 5, 2018
Study Record Updates
Last Update Posted (Actual)
December 5, 2018
Last Update Submitted That Met QC Criteria
December 4, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Eye Diseases
- Retinal Diseases
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Eye Diseases, Hereditary
- Eye Neoplasms
- Retinal Neoplasms
- Wounds and Injuries
- Retinoblastoma
Other Study ID Numbers
- yanghs201812
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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