Clinical Evaluation of Polarized Light Assisted Colposcopy

NCT01349621 | Completed

• 2 other identifiers: CA1561661R21CA156166-01A1
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study to compare unpolarized (conventional) to polarized light colposcopy. Subjects will be asked to participate in the study when they arrive for their prescheduled colposcopic examination. The study doctor will use a conventional or standard colposcope to perform the examination. His/her impression of the exam will be noted and if necessary a biopsy specimen will be obtained. The study doctor will then perform a colposcopy using a polarized light. His/her impression of the exam will be noted and a biopsy specimen will be obtained if necessary. This study is designed to test the hypothesis that polarized light colposcopy is more sensitive and more specific than standard, un-polarized light colposcopy.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Abnormal Pap results; Colposcopy

Outcome Measures

Primary Outcomes (1)

• To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated.

  We will examine 300 women scheduled for colposcopy using unpolarized and polarized light. To determine whether polarized light increases the sensitivity and specificity over unpolarized light, the area under a receiver operating characteristic curve (AROC) will be calculated. We anticipate that it will take approximately 8-10 months to enroll 300 subjects.

  8-10 months

Secondary Outcomes (1)

• We will determine the differences in the severity of cervical neoplasia between biopsies taken using polarized and unpolarized light using a Bowker's test of symmetry.

  8-10 months

Study Arms (1)

Standard and polarized light colposcopy

Standard and polarized light colposcopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy women with a previously detected abnormal cervical cytology or other indication for colposcopy

You may qualify if:

• Subject is female, 18 years or older
• Subject has previously detected abnormal cervical cytology or other indication for colposcopy
• Subject fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent

You may not qualify if:

• Subject is pregnant or may be pregnant
• Subject has known allergy to acetic acid
• Subject has thrombocytopenia or other coagulation disorder that would contraindicate obtaining multiple cervical biopsies
• Subject is concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
• Subject has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate
• Subject has clinical evidence of gross purulent cervicitis
• Subject has a recent history of acute cervicitis
• Subject does not have an intact cervix uteri or has more than one cervix uteri

Sponsors & Collaborators

• Augusta University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Daron Ferris, MD

  Geogia Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Family Medicine and Obstetrics and Gynecology

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: April 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2012-09

Locations

US (1)