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CompletedNCT00084903Updated Aug 2, 2012

Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears

An interventional study of Colposcopic biopsy and Light-Scattering Spectroscopy in Cervical Cancer and Precancerous Condition, sponsored by M.D. Anderson Cancer Center. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-02.

Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
1,070
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninvasively detect cervical intraepithelial neoplasia and dysplasia.

PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.

Read the detailed description

OBJECTIVES:

  • Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
  • Determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix.
  • Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
  • Determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants.
  • Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.

OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.

NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured

PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.

02

Conditions studied

  • Cervical Cancer
  • Precancerous Condition

Keywords

  • cervical cancer
  • cervical intraepithelial neoplasia
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's enrollment of 1,070 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
  2. Subjects must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant individuals will be ineligible for this study.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,070 participants (actual)

Study arms

  • Experimental
    Fluorescence Spectroscopy

    Procedure: Colposcopic biopsy · Procedure: Light-Scattering Spectroscopy

Interventions

  • ProcedureColposcopic biopsy

    Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.

    Also known as: biopsy

  • ProcedureLight-Scattering Spectroscopy

    Spectroscopy readings taken in 2 regions of cervix.

    Also known as: Spectroscopy, Fluorescence spectroscopy

06

What researchers measure

Primary outcomes

  1. Fluorescent Measurements of Cervix

    Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.

    Time frame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.

07

Study locations

2 sites
  • M. D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030-4009, United States
  • British Columbia Cancer Agency - Vancouver Cancer Centre
    Vancouver, British Columbia V5Z 4E6, Canada
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00084903
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 11, 2004
Start date
Apr 1998
Primary completion
Jul 2007
Completion
Feb 2009
Last update
Aug 2, 2012

Study contacts

Helen Rhodes, MD
study chair · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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