Cervical Cancer Detection Using Optical Spectroscopy

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Device: Optical Spectroscopy Bench-Top System; Device: Portable Optical Spectrometer; Device: Transvaginal colposcope

• Registration Number: NCT00900575
• Lead Sponsor: Duke University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-09
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 350

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colposcope	Optical Spectroscopy Bench-Top System	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
Colposcope	Portable Optical Spectrometer	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
Colposcope	Transvaginal 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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States