Cervical Cancer Detection Using Optical Spectroscopy
Overview
- Phase
- Not Applicable
- Intervention
- Optical Spectroscopy Bench-Top System
- Conditions
- Cervical Cancer
- Sponsor
- Duke University
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Identification of optical signatures of cervical tissue
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Investigators
Eligibility Criteria
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
Arms & Interventions
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
Intervention: Optical Spectroscopy Bench-Top System
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
Intervention: Portable Optical Spectrometer
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
Intervention: Transvaginal colposcope
Outcomes
Primary Outcomes
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.