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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach

3 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

Study Start

First participant enrolled

September 1, 2002

Completed

4.9 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed

Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

6.4 years

First QC Date

August 7, 2007

Last Update Submit

July 31, 2012

Conditions

Cervical Cancer

Keywords

Digital Colposcopy for FluorescenceDCFFluorescence SpectroscopyDigital ColposcopyDCCervical Intraepithelial NeoplasiaCervical CancerCervixVaginaLesions of the cervixPrecancerous lesions

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Digital Colposcopy

Digital Colposcopy for Fluorescence (DCF)

Procedure: Colposcopy

Interventions

ColposcopyPROCEDURE

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.

Digital Colposcopy

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Women 18 and older with an abnormal PAP.

You may qualify if:

Women 18 and older with an abnormal Pap

You may not qualify if:

Pregnant individuals will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

M.D. Anderson Cancer Centerlead
National Cancer Institute (NCI)collaborator

Study Sites (5)

Lyndon B. Johnson Hospital

Houston, Texas, 77030, United States

Location

U.T. Health Science Center

Houston, Texas, 77030, United States

Location

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

British Columbia Cancer Research Center

Vancouver, British Columbia, Canada

Location

University College Hospital

Ibadan, Oyo State, Nigeria

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPrecancerous Conditions

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

Michele Follen, MD, PhD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2007

First Posted

August 8, 2007

Study Start

September 1, 2002

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(3)CA(1)NG(1)

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Digital Colposcopy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Digital Colposcopy

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations