NCT01884194

Brief Summary

MRI is useful for diagnosing pinealoblastoma in retinoblastoma patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

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

First Submitted

Initial submission to the registry

May 24, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

December 29, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

May 24, 2013

Last Update Submit

December 28, 2015

Conditions

RetinoblastomaPineoblastoma

Keywords

retinoblastomapineoblastoma

Outcome Measures

Primary Outcomes (1)

  • Malignancy criteria of pineal gland

    size of pineal gland solid or cystic component (all at baseline)

    clinical follow-up 1-year after baseline imaging

Study Arms (2)

Retinoblastoma patients

patients with diagnosed retinoblastoma

non-retinoblastoma patients

aged matched control cohort without the diagnosis of ocular or brain tumor

Eligibility Criteria

Age1 Day - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients with retinoblastoma

You may qualify if:

  • diagnosis of retinoblastoma
  • brain MRI available

You may not qualify if:

  • insufficient quality of brain MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite Hospital Berlin

Berlin, State of Berlin, 12200, Germany

Location

Related Publications (1)

  • Pham TT, Siebert E, Asbach P, Willerding G, Erb-Eigner K. Magnetic resonance imaging based morphologic evaluation of the pineal gland for suspected pineoblastoma in retinoblastoma patients and age-matched controls. J Neurol Sci. 2015 Dec 15;359(1-2):185-92. doi: 10.1016/j.jns.2015.10.046. Epub 2015 Oct 28.

    PMID: 26671110DERIVED

MeSH Terms

Conditions

RetinoblastomaPinealoma

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 DiseasesBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral candidate

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 21, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

December 29, 2015

Record last verified: 2015-12

Locations

DE(1)