Effectiveness and Possible Complications of Core Needle B... | NCT01772355

Studies
Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

NCT01772355

Sponsor

Yarovoy Andrey

Status

Unknown status

Last Update Posted

Jan 21, 2013Estimated

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Orbial Mass Lesion

Interventions

semi automated core needle biopsy of orbital tumors

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2012Actual

Completion Date

Jun 2014Estimated

First Submitted Date

Jan 17, 2013

First Submission Date that Met QC Criteria

Jan 17, 2013

First Posted Date

Jan 21, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2013

Last Update Posted Date

Jan 21, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yarovoy Andrey, MD, PhD, head ocular oncology department, The S.N. Fyodorov Eye Microsurgery State InstitutionSponsor-Investigator

Lead Sponsor

Yarovoy AndreyOTHER_GOV

Collaborators

Not provided

Description Module

Brief Summary

Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure that provides a sufficient amount of tissue material for standard histological and immunohistochemical analysis and can be an alternative or supplement to fine needle aspiration biopsy

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tissue core	Other	semi automated core needle biopsy of the orbital tumors	Device: semi automated core needle biopsy of orbital tumors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
semi automated core needle biopsy of orbital tumors	Device		tissue core

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
true identification of an orbital tumor with a core needle biopsy		five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification

Exclusion Criteria:

An anti-coagulant therapy at the time of biopsy,
bleeding diathesis,
suspected hypervascular lesions,
orbital roof destruction with a tumor,
apical location of the tumor

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrey A Yarovoy, MD	Contact	+74994888943		yarovoyaa@yandex.ru

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The S.Fyodorov Eye Microsurgery Federal State Institution	Recruiting	Moscow		127486	Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23515750	Derived	Yarovoy AA, Bulgakova ES, Shatskikh AV, Uzunyan DG, Kleyankina SS, Golubeva OV. CORE needle biopsy of orbital tumors. Graefes Arch Clin Exp Ophthalmol. 2013 Aug;251(8):2057-61. doi: 10.1007/s00417-013-2315-6. Epub 2013 Mar 21.