Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250055
First received: November 3, 2005
Last updated: May 10, 2016
Last verified: May 2016

November 3, 2005
May 10, 2016
April 2004
December 2007   (final data collection date for primary outcome measure)
The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions. [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00250055 on ClinicalTrials.gov Archive Site
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Non-Invasive, Real-Time Technology for Diagnosis of Cervical Tissue
Non-Invasive, Real-time Technology for Diagnosis of Cervical Tissue

In general, to determine the sensitivity of light transport to tissue from morphological features of clinical significance.

Determine how specific structural features contribute to light scattering. Investigate light scattering differences in tumorigenic and nontumorigenic cells.

Develop and implement quantitative and sensitive methods for measuring morphological properties.

Clinical measurements.

Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra biopsy of suspicious tissue.
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Cervix
  • Cancer
Procedure: Colposcopy, Spectroscopy, and Biopsy
During the colposcopy or LEEP (Loop Electrical Excision Procedure) procedure, or during pelvic exams before surgery after the doctor applies 3% acetic acid to the cervix, the doctor then positions the colposcope to take pictures of the patient's cervix. Digital pictures are taken of the patient's cervix under white light using a colposcopy imaging system. These pictures are annotated by the doctor during the appointment to mark the spectroscopy sites.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2010
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with abnormal Pap smears who are referred for colposcopy.

Exclusion criteria include:

  • Anyone of the male sex since this study focuses on cervical cell abnormalities
  • Any woman who has had a hysterectomy, LEEP, or chemotherapy.
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00250055
1104C
Yes
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University of New Mexico
University of New Mexico
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Principal Investigator: Harriet Smith, MD University of New Mexico
University of New Mexico
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP