Cervical Cancer Detection Using Optical Spectroscopy

Duke University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Device: Transvaginal colposcope; Device: Optical Spectroscopy Bench-Top System; Device: Portable Optical Spectrometer

Study type: Interventional

Funder types: Other

Identifiers

NCT00900575

Pro00008173

Details and patient eligibility

About

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

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

350 participants in 1 patient group

Colposcope

Experimental group

Description:

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

Treatment:

Device: Portable Optical Spectrometer

Device: Optical Spectroscopy Bench-Top System

Device: Transvaginal colposcope