Measurement of Digital Colposcopy for Fluorescence Spectr... | NCT00513123

Studies
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

NCT00513123

Sponsor

M.D. Anderson Cancer Center

Status

Completed

Last Update Posted

Aug 1, 2012Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Cervical Cancer

Interventions

Colposcopy

Countries

United States
Canada
Nigeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Aug 7, 2007

First Submission Date that Met QC Criteria

Aug 7, 2007

First Posted Date

Aug 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2012

Last Update Posted Date

Aug 1, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.

Other Objectives:

To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
To evaluate the effect of acetic acid in the image contrast obtained.
Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.

Detailed Description

DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).

DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.

Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.

This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Digital Colposcopy		Digital Colposcopy for Fluorescence (DCF)	Procedure: Colposcopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colposcopy	Procedure	As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.		7 Years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women 18 and older with an abnormal Pap

Exclusion Criteria:

Pregnant individuals will be excluded from this study

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Women 18 and older with an abnormal PAP.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michele Follen, MD, PhD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lyndon B. Johnson Hospital		Houston	Texas	77030	United States
U.T. Health Science Center

Label	URL
UT MD Anderson Cancer Center website	View source

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002578	Uterine Cervical Dysplasia

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003127	Colposcopy

Ancestor Terms

ID	Term
D003944	Diagnostic Techniques, Obstetrical and Gynecological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D004724	Endoscopy

Browse Leaves

Not provided

Browse Branches

Not provided