NCT03764930

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 1, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

5.6 years

First QC Date

December 1, 2018

Last Update Submit

December 4, 2018

Conditions

RetinoblastomaWounds and Injury

Outcome Measures

Primary Outcomes (1)

  • Survival Status

    Outcome at last follow-up

    between January 2013 and August 2018

Secondary Outcomes (2)

  • Trauma incidence of RB patients

    between January 2013 and August 2018

  • RB incidence of pre-school patients with trauma history

    between January 2013 and August 2018

Interventions

Unsuspected RetinoblastomaOTHER

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

Eligibility Criteria

Age1 Month - 80 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those children who experienced accidental ocular trauma with or without brain involvement before diagnosis of unsuspected RB was studied.

You may qualify if:

  • 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.

You may not qualify if:

  • The patients who didn't have undergone trauma before diagnosis of RB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

RetinoblastomaWounds and Injuries

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Study Officials

  • Huasheng Yang, MD,PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Orbital Diseases and Ocular Oncology, Clinical Professor

Study Record Dates

First Submitted

December 1, 2018

First Posted

December 5, 2018

Study Start

January 1, 2013

Primary Completion

August 1, 2018

Study Completion

November 30, 2018

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations

CN(1)