NCT00865813

Brief Summary

The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2008

Status
unknown

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

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 19, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

March 18, 2009

Last Update Submit

March 18, 2009

Conditions

Tumor

Keywords

Punch biopsy,perioculartumors.

Outcome Measures

Primary Outcomes (1)

  • accuracy, positive predictive value, negative predictive value, sensitivity, specificity

    In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Study Arms (1)

Punch Biopsy

EXPERIMENTAL
Procedure: Punch Biopsy

Interventions

Punch BiopsyPROCEDURE

1. 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

Also known as: Punch 2 mm, Biopsy
Punch Biopsy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Lesions with not malignant characteristics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Rachel C Carneiro

    University of Sao Paulo - Hospital das Clinicas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2009

First Posted

March 19, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

March 19, 2009

Record last verified: 2009-03