TumorNCT00865813
Biopsy Incisional With Trepan in Periocular Lesions
A study testing Punch Biopsy in people with Tumor, run by University of Sao Paulo.
Trial summary
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tumor
- What is being tested?
- Punch Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2009
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included.
Who cannot join
- Lesions with not malignant characteristics
About this study
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.
Read the detailed description
In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
- Conditions
- Tumor
- Being tested
- Punch Biopsy
- Keywords
- Punch biopsy,, periocular, tumors.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Punch BiopsyProcedure or surgery
Also called Punch 2 mm, Biopsy
- Instillation of anesthetic eye drops.
- Asepsis
- Placement of surgical cloths and drapes
- Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution.
- Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions
- Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade
| Study group | Role | What they receive |
|---|---|---|
| Punch Biopsy | Experimental | Not described Receives: Procedure: Punch Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy, positive predictive value, negative predictive value, sensitivity, specificity
Measured: In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startDec 2008
- Primary completionOct 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rachel C Carneiro, Principal investigator, University of Sao Paulo - Hospital das Clinicas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865813
- Sponsor's protocol ID
- 1143/07
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2009
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsy Incisional With Trepan in Periocular Lesions
- ClinicalTrials.gov ID
- NCT00865813
- Acronym / sponsor ID
- 1143/07
- Conditions
- Tumor
- Keywords
- Punch biopsy,, periocular, tumors.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Mar 2009 (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.
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.
Detailed description
In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Punch Biopsy | Experimental | Procedure: Punch Biopsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included.
Key exclusion criteria (1 listed)
- Lesions with not malignant characteristics
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 |
|---|---|---|
| Punch BiopsyAlso: Punch 2 mm, Biopsy1. Instillation of anesthetic eye drops. 2. Asepsis 3. Placement of surgical cloths and drapes 4. Infiltration of the involved region with anesthetic solution plus adrenalin in1:200.00 dilution. 5. Trephination of the most typical area of the lesion with a punch (2mm in diameter) of stainless steel by applying gentle pressure and twisting the trephine until its introduction into the suspicious lesions 6. Removal of the excised tissue with the aid of an insulin needle or conjuntival forceps, the base then bein cut with an number 11 surgical blade | Procedure or surgery | Punch Biopsy |
Primary outcome
accuracy, positive predictive value, negative predictive value, sensitivity, specificity
Time frame: In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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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.
Rachel C Carneiro principal investigator
University of Sao Paulo - Hospital das Clinicas
Questions about this trial
What is this clinical trial studying?
A study testing Punch Biopsy in people with Tumor, run by University of Sao Paulo.
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 1 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 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy, positive predictive value, negative predictive value, sensitivity, specificity (time frame: In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2009.