Digital Colposcopy in Finding Cervical Intraepithelial Ne... | NCT00602368

Studies
Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

NCT00602368

Sponsor

British Columbia Cancer Agency

Status

Completed

Last Update Posted

Feb 1, 2017Estimated

Enrollment

114Actual

Phase

Not Applicable

Conditions

Cervical Cancer
Precancerous Condition

Interventions

histological technique
laboratory biomarker analysis
colposcopic biopsy
colposcopy
light-scattering spectroscopy
loop electrosurgical excision procedure

Countries

Canada

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

ID	Type	Description	Link
BCCR-H03-61235	Other Identifier	UBC-BCCA REB
P01CA082710	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jan 2017

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

Dec 2010

Primary Completion Date

Dec 2014Actual

Completion Date

May 2015Actual

First Submitted Date

Jan 25, 2008

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Jan 28, 2008Estimated

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

Jan 30, 2017

Last Update Posted Date

Feb 1, 2017Estimated

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

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia.

PURPOSE: This clinical trial is studying digital colposcopy to see how well it works in finding cervical intraepithelial neoplasia.

Detailed Description

OBJECTIVES:

To identify potential improvements for a noninvasive method of diagnosing cervical dysplasia and neoplasia using digital colposcopy and fluorescence spectroscopic imaging.
To measure fluorescence and reflectance images of the human cervix in vivo using digital colposcopy.
To evaluate the effect of acetic acid on the image contrast obtained.
To compare the device performance with colposcopic impression and histopathologic interpretation of tissue removed by standard loop electrosurgical excision procedure (LEEP).

OUTLINE: This is a multicenter study.

Participants undergo routine colposcopy as part of their regular colposcopic evaluation. The digital colposcope is used to take fluorescence and reflectance images of the vagina and cervix. Participants also undergo loop electrosurgical excision procedure (LEEP). The digital colposcopic images are compared with tissue removed during LEEP. Additional surrogate biomarkers under development are also measured using tissue samples removed during LEEP, such as quantitative histopathology measurements, DNA tests for the copy number changes, and tests for the incorporation of viral HPV DNA.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

114Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
histological technique	Other
laboratory biomarker analysis	Other
colposcopic biopsy	Procedure
colposcopy	Procedure
light-scattering spectroscopy	Procedure
loop electrosurgical excision procedure	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feasibility of digital colposcopy & fluorescence spectroscopy as a tool for early diagnosis of CIN	Measure normal and abnormal sites during colposcopy and compare this to pathology.	For length of study

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Criteria:

Inclusion criteria:

Included subjects will be ≥18 years old.
Included subjects will not be pregnant.
Included subjects will have a negative urine pregnancy test.
Included subjects will be scheduled for colposcopy and/or LEEP treatment at the VGH Women's Clinic.
Included subjects will indicate understanding of the study.
Included subjects will provide informed consent to participate.

Exclusion criteria:

Individuals <18 years old will be excluded.
Pregnant individuals will be excluded.
Individuals that have had an operation to remove their cervix will be excluded.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dianne M. Miller, M.D.	British Columbia Cancer Agency, Vancouver General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BC Cancer Research Centre		Vancouver	British Columbia	V5Z 1L3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D011230	Precancerous Conditions
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
D006652	Histological Techniques
D003127	Colposcopy

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided