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Cervical Cancer Detection Using Optical Spectroscopy

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT00900575
Collaborator
(none)
350
Enrollment
1
Location
1
Arm
200
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Condition or Disease Intervention/Treatment Phase
  • Device: Optical Spectroscopy Bench-Top System
  • Device: Portable Optical Spectrometer
  • Device: Transvaginal colposcope
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Cervical Cancer Detection Using Optical Spectroscopy
Actual Study Start Date :
May 1, 2006
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colposcope

Patients referred for GYN procedures. Specifically, patients will be referred for Pap smear, colposcope 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, Pocket colposcope, callascope

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Identification of optical signatures of cervical tissue [Day of procedure (less than 10 minutes)]

      The primary outcome of this study is the identification of the optical signatures of cervical tissue.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • undergoing colposcopy for the diagnosis of cervical cancer

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

    • Follow-up Pap smear in surveillance

    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

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Nimmi Ramanujam, Ph.D., Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT00900575
    Other Study ID Numbers:
    • Pro00008173
    First Posted:
    May 13, 2009
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Mar 1, 2022
    Keywords provided by Duke University
    cervical cancer
    LEEP
    colposcopy
    Pap smear
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Apr 25, 2022