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A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

18 Years
Not Enrolling
Cervical Cancer

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Trial Information

A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

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.

Inclusion Criteria:

- Women 18 and older with an abnormal Pap

Exclusion Criteria:

- Pregnant individuals will be excluded from this study

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

7 Years

Safety Issue:


Principal Investigator

Michele Follen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2002

Completion Date:

February 2009

Related Keywords:

  • Cervical Cancer
  • Digital Colposcopy for Fluorescence
  • DCF
  • Fluorescence Spectroscopy
  • Digital Colposcopy
  • DC
  • Cervical Intraepithelial Neoplasia
  • Cervical Cancer
  • Cervix
  • Vagina
  • Lesions of the cervix
  • Precancerous lesions
  • Neoplasms
  • Uterine Cervical Neoplasms
  • Cervical Intraepithelial Neoplasia
  • Carcinoma in Situ



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030
Lyndon B. Johnson HospitalHouston, Texas  77030
U.T. Health Science CenterHouston, Texas  77030