Orbial Mass LesionNCT01772355
Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors
A study testing semi automated core needle biopsy of orbital tumors in people with Orbial Mass Lesion, run by Yarovoy Andrey at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orbial Mass Lesion
- What is being tested?
- semi automated core needle biopsy of orbital tumors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2008to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
The S.Fyodorov Eye Microsurgery Federal State Institution
Moscow, 127486
Andrey A Yarovoy, MD, +74994888943, yarovoyaa@yandex.ru
About this study
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
- Conditions
- Orbial Mass Lesion
- Being tested
- semi automated core needle biopsy of orbital tumors
- Keywords
- orbit; tumor; core biopsy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi automated core needle biopsy of orbital tumorsDevice
| Study group | Role | What they receive |
|---|---|---|
| tissue core | Other | semi automated core needle biopsy of the orbital tumors Receives: Device: semi automated core needle biopsy of orbital tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
true identification of an orbital tumor with a core needle biopsy
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startOct 2008
- Primary completionDec 2012
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orbial Mass LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yarovoy Andrey
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772355
- Sponsor's protocol ID
- core biopsy of orbital tumors
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2013
- Last updated
- 21 Jan 2013
- Results posted
- No
Publications
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.
PubMed 23515750
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors
- ClinicalTrials.gov ID
- NCT01772355
- Acronym / sponsor ID
- core biopsy of orbital tumors
- Conditions
- Orbial Mass Lesion
- Keywords
- orbit; tumor; core biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Yarovoy AndreyOther government
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tissue core | Other | Device: semi automated core needle biopsy of orbital tumorssemi automated core needle biopsy of the orbital tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semi automated core needle biopsy of orbital tumors | Device | tissue core |
Primary outcome
true identification of an orbital tumor with a core needle biopsy
Time frame: five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2013.
- Derived from this study: PubMed 23515750Yarovoy 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing semi automated core needle biopsy of orbital tumors in people with Orbial Mass Lesion, run by Yarovoy Andrey at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey A Yarovoy, MD (+74994888943, yarovoyaa@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
true identification of an orbital tumor with a core needle biopsy (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2013.