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

NCT00250055 | Terminated DMC

• 1 other identifier: 1104C
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervix; Cancer

Keywords

NIH; Non-Invasive diagnosis of cervical tissue; Los Alamos/NIH

Outcome Measures

Primary Outcomes (1)

• The objective of this study is to determine whether non-invasive measurements of light transport through tissue can identify pre-cancerous and cancerous conditions.

  6 years

Interventions

Colposcopy, Spectroscopy, and Biopsy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anyone of the male sex since this study focuses on cervical cell abnormalities
• Any woman who has had a hysterectomy, LEEP, or chemotherapy.

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Colposcopy; Spectrum Analysis; Biopsy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Chemistry Techniques, Analytical; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling

Study Officials

• Harriet Smith, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2005
• First Posted: November 7, 2005
• Study Start: April 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2010
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

US (1)