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Biopsy Incisional With Trepan in Periocular Lesions

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by University of Sao Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00865813
First Posted: March 19, 2009
Last Update Posted: March 19, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

Condition Intervention
Tumor Procedure: Punch Biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Biopsy Incisional With Trepan in Periocular Lesions

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 40
Study Start Date: December 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Punch Biopsy Procedure: Punch Biopsy
  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
Other Names:
  • Punch 2 mm
  • Biopsy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Lesions with not malignant characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865813


Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rachel C Carneiro University of Sao Paulo - Hospital das Clinicas
  More Information

Responsible Party: Suzana Matayoshi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00865813     History of Changes
Other Study ID Numbers: 1143/07
First Submitted: March 18, 2009
First Posted: March 19, 2009
Last Update Posted: March 19, 2009
Last Verified: March 2009

Keywords provided by University of Sao Paulo:
Punch biopsy,
periocular
tumors.


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