Cervical Cancer Detection Using Optical Spectroscopy

January 9, 2024 updated by: Duke University
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nimmi Ramanujam, Ph.D.
  • Phone Number: 919-660-5307
  • Email: nimmi@duke.edu

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Nimmi Ramanujam, Ph.D.
        • Sub-Investigator:
          • John Schmitt, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of procedure (less than 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2006

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

May 11, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimated)

May 13, 2009

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00008173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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