Cervical Cancer Detection Using Optical Spectroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00900575
First received: May 11, 2009
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The objective of the work described in this protocol is to apply the angled illumination probe for diffuse reflectance and fluorescence-based diagnosis of epithelial pre-cancers and cancers in the uterine cervix and demonstrate its diagnostic potential for cervical pre-cancers and cancers.


Condition Intervention
Cervical Cancer
Device: Optical Spectroscopy Bench-Top System
Device: Portable Optical Spectrometer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cervical Cancer Detection Using Optical Spectroscopy

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Identification of optical signatures of cervical tissue [ Time Frame: Day of procedure (less than 10 minutes) ] [ Designated as safety issue: No ]
    The primary outcome of this study is the identification of the optical signatures of cervical tissue.


Estimated Enrollment: 310
Study Start Date: May 2006
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duke Arm
patients referred for colposcopically directed biopsy or LEEP. The intervention for this arm is the use of the bench-top optical spectrometer.
Device: Optical Spectroscopy Bench-Top System
This device is a bench-top optical spectrometer
Device: Portable Optical Spectrometer
This device is a portable optical spectrometer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • undergoing colposcopy for the diagnosis of cervical cancer
  • LEEP for the treatment of cervical cancer in early stages.

Exclusion Criteria:

  • Women under the age of 18 (minors) will be excluded from this study.
  • patients less than 10 weeks or more than 34 weeks pregnant will be excluded.
  • patients will be excluded if she has had a recent episode of bleeding or preterm labor.
  • Subjects who are not competent to give consent will excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900575

Contacts
Contact: Nimmi Ramanujam, Ph.D. 919-660-5307 nimmi@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Nimmi Ramanujam, Ph.D.         
Principal Investigator: David Walmer, M.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Nimmi Ramanujam, Ph.D. Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00900575     History of Changes
Other Study ID Numbers: Pro00008173
Study First Received: May 11, 2009
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
cervical cancer
LEEP
colposcopy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 20, 2014