NCT00632190

Brief Summary

RATIONALE: New diagnostic procedures, such as spectroscopy, may be a less invasive way to check for dysplasia and neoplasia in the cervix. Spectroscopy may also used as a screening test to help doctors find cervical cancer sooner, when it may be easier to treat. PURPOSE: This clinical trial is studying how well spectroscopy works in diagnosing dysplasia and neoplasia in the cervix in women undergoing colposcopy or Pap testing.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
Last Updated

January 28, 2010

Status Verified

January 1, 2009

Enrollment Period

3.2 years

First QC Date

March 7, 2008

Last Update Submit

January 27, 2010

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 1cervical intraepithelial neoplasia grade 2cervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (4)

  • Measurement of reflection and fluorescence spectra in vivo of sites in the human cervix

  • Refinement of fluorescence spectroscopy for detection of cervical lesions via better classification of normal columnar tissue and non-neoplastic tissue with inflammation, and low- and high-grade squamous intraepithelial lesions

  • Validation of wavelength selections for the spectroscopy device derived from in vitro measurements

  • Sensitivity and specificity of this device for the diagnosis of cervical intraepithelial neoplasia

Interventions

fluorophotometryOTHER
colposcopic biopsyPROCEDURE
colposcopyPROCEDURE
light-scattering spectroscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Referred to the Colposcopy clinic at Vancouver General Hospital, the MD Anderson Cancer Center, or the University of Texas at Austin * Abnormal or normal Papanicolaou smear * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre or post-menopausal * Not pregnant PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

Interventions

FluorophotometryColposcopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesDiagnostic Techniques, Obstetrical and GynecologicalEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Sylvia Lam

    British Columbia Cancer Agency

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 10, 2008

Study Start

January 1, 2000

Primary Completion

March 1, 2003

Last Updated

January 28, 2010

Record last verified: 2009-01