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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervix, Cancer

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Trial Information

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


Patients undergoing a colposcopy will also have spectroscopy measurements taken and an extra
biopsy of suspicious tissue.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

6 years

Safety Issue:

Yes

Principal Investigator

Harriet Smith, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

1104C

NCT ID:

NCT00250055

Start Date:

April 2004

Completion Date:

January 2010

Related Keywords:

  • Cervix
  • Cancer
  • NIH
  • Non-Invasive diagnosis of cervical tissue
  • Los Alamos/NIH

Name

Location

University of New Mexico Albuquerque, New Mexico  87131