Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

NCT ID: NCT01772355

Last Updated: 2013-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Orbial Mass Lesion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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tissue core

semi automated core needle biopsy of the orbital tumors

Group Type OTHER

semi automated core needle biopsy of orbital tumors

Intervention Type DEVICE

Interventions

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semi automated core needle biopsy of orbital tumors

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yarovoy Andrey

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yarovoy Andrey

MD, PhD, head ocular oncology department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The S.Fyodorov Eye Microsurgery Federal State Institution

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Andrey A Yarovoy, MD

Role: CONTACT

+74994888943

Facility Contacts

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Andrey A Yarovoy, MD

Role: primary

+74994888943

References

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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.

Reference Type DERIVED
PMID: 23515750 (View on PubMed)

Other Identifiers

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core biopsy of orbital tumors

Identifier Type: -

Identifier Source: org_study_id

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