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Cervical Cancer Detection Using Optical Spectroscopy

Primary Purpose

Cervical Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Optical Spectroscopy Bench-Top System

Portable Optical Spectrometer

Transvaginal colposcope

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring cervical cancer, LEEP, colposcopy, Pap smear

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colposcope

Arm 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

Outcomes

Primary Outcome Measures

Identification of optical signatures of cervical tissue

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00900575

First Posted

May 11, 2009

Last Updated

January 19, 2023

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT00900575

Brief Title

Cervical Cancer Detection Using Optical Spectroscopy

Official Title

Cervical Cancer Detection Using Optical Spectroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 2006 (Actual)

Primary Completion Date

January 31, 2024 (Anticipated)

Study Completion Date

January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

cervical cancer, LEEP, colposcopy, Pap smear

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colposcope

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Optical Spectroscopy Bench-Top System

Intervention Description

This device is a bench-top optical spectrometer

Intervention Type

Device

Intervention Name(s)

Portable Optical Spectrometer

Intervention Description

This device is a portable optical spectrometer

Intervention Type

Device

Intervention Name(s)

Transvaginal colposcope

Other Intervention Name(s)

TVDC, Transvaginal digital colposcope, Pocket colposcope, callascope

Primary Outcome Measure Information:

Title

Identification of optical signatures of cervical tissue

Description

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

Time Frame

Day of procedure (less than 10 minutes)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nimmi Ramanujam, Ph.D.

Phone

919-660-5307

nimmi@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nimmi Ramanujam, Ph.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nimmi Ramanujam, Ph.D.

First Name & Middle Initial & Last Name & Degree

John Schmitt, M.D.

12. IPD Sharing Statement

Citations:

PubMed Identifier

19308287

Citation

Chang VT, Cartwright PS, Bean SM, Palmer GM, Bentley RC, Ramanujam N. Quantitative physiology of the precancerous cervix in vivo through optical spectroscopy. Neoplasia. 2009 Apr;11(4):325-32. doi: 10.1593/neo.81386.

Results Reference

result

PubMed Identifier

33024146

Citation

Asiedu MN, Agudogo JS, Dotson ME, Skerrett E, Krieger MS, Lam CT, Agyei D, Amewu J, Asah-Opoku K, Huchko M, Schmitt JW, Samba A, Srofenyoh E, Ramanujam N. A novel speculum-free imaging strategy for visualization of the internal female lower reproductive system. Sci Rep. 2020 Oct 6;10(1):16570. doi: 10.1038/s41598-020-72219-9.

Results Reference

derived

Links:

URL

https://www.globalwomenshealthtechnologies.com/

Description

PI website to see ongoing research

Learn more about this trial

Cervical Cancer Detection Using Optical Spectroscopy

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