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Cervical Cancer Detection Using Optical Spectroscopy

This study is currently recruiting participants.
Verified April 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900575
First Posted: May 13, 2009
Last Update Posted: April 27, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  Purpose
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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) ]
    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 2018
Estimated Primary Completion Date: June 2018 (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, miniature optical spectrometer or trans-vaginal colposcope
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
Device: Transvaginal colposcope
Other Names:
  • TVDC
  • Transvaginal digital colposcope

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 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
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): 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.         
Sub-Investigator: John Schmitt, 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
First Submitted: May 11, 2009
First Posted: May 13, 2009
Last Update Posted: April 27, 2017
Last Verified: April 2017

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