ClinicalTrials.gov
ClinicalTrials.gov Menu

Attention to Retinoblastoma Diagnosed in the Trauma Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03764930
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Huasheng Yang, Sun Yat-sen University

Brief Summary:
To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.

Condition or disease Intervention/treatment
Retinoblastoma Wounds and Injury Other: Unsuspected 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 Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Attention to Retinoblastoma Diagnosed in the Trauma Setting
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Unsuspected Retinoblastoma
    To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.


Primary Outcome Measures :
  1. Survival Status [ Time Frame: between January 2013 and August 2018 ]
    Outcome at last follow-up


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 80 Years   (Child, Adult, Older Adult)
Sexes 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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764930


Locations
China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Huasheng Yang, MD,PhD Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party: Huasheng Yang, Head of Orbital Diseases and Ocular Oncology, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03764930     History of Changes
Other Study ID Numbers: yanghs201812
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Eye Diseases
Retinoblastoma
Wounds and Injuries
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Retinal Diseases