Clinical trial NCT00513123: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
Official title: A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Digital Colposcopy for Fluorescence
DCF
Fluorescence Spectroscopy
Digital Colposcopy
DC
Cervical Intraepithelial Neoplasia
Cervical Cancer
Cervix
Vagina
Lesions of the cervix
Precancerous lesions
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 18 and older with an abnormal PAP.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Women 18 and older with an abnormal Pap

Exclusion Criteria:

* Pregnant individuals will be excluded from this study

Primary outcomes:
measure: To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.
timeFrame: 7 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson Hospital
state: Texas
city: Houston
country: United States
facility: U.T. Health Science Center
state: Texas
city: Houston
country: United States
facility: U.T.M.D. Anderson Cancer Center
state: Texas
city: Vancouver
country: Canada
facility: British Columbia Cancer Research Center
state: British Columbia
city: Ibadan
country: Nigeria
facility: University College Hospital
state: Oyo State
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michele Follen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: