A Randomized Trial of Spectroscopy Versus Standard Care in Cervical Intraepithelial Neoplasia
A colposcopy is an exam of the cervix, using a magnifying lens. Fluorescence spectroscopy
uses a special light source to look for abnormal cells during the colposcopy.
If you agree to take part in this study, depending on your referral Pap smear diagnosis, you
will be randomly assigned (as in the toss of a coin) to one of 3 groups. Participants in
Group 1 will undergo a standard colposcopy. Participants in Group 2 will undergo a
colposcopy plus fluorescence spectroscopy. If your referral Pap smear diagnosis is
high-grade dysplasia (abnormal tissue), you may be assigned to Group 3. Participants in
Group 3 will have a colposcopy exam and a loop electrical excision procedure (LEEP--a
procedure where a small heated wire loop is used to remove a cone-shaped piece of abnormal
tissue) on the same day.
At Visit 1, your complete medical history will be recorded. You will have a physical exam.
You will have a colposcopy. You will have a pap smear, and cultures will be taken for
gonorrhea and chlamydia. The bodily fluid samples for the cultures are collected by using a
cotton swab or cytobrush (the same kind of brush used to collect cells for a Pap smear) to
collect mucous from the canal of the cervix. Blood (about 6 teaspoons) may be drawn for
syphilis, hepatitis, and Human Immunodeficiency Virus (HIV) tests. You may have a Human
Papilloma Virus (HPV) test. The HPV test is performed in the same manner as the bodily fluid
sample collection. Depending on which arm you are assigned to, you may have an endocervical
curette (ECC) and cervical biopsies of abnormal areas. Before you begin the study, you
should ask your study doctor whether or not you were assigned to the group that will be
receiving the ECC and cervical biopsies. During the ECC, cells/tissue will be scraped from
the cervical canal with an instrument which is made to only take cells/tissue from the
surface of the cervical canal. A cervical biopsy is when a tiny piece of tissue from the
outside surface of the cervix is removed. Women who are able to have children must have a
negative urine pregnancy test. You will complete a behavioral risk-factor interview and
questionnaire. The questionnaire should take about 10 minutes to complete.
If you are in Group 2, at each visit you will have a picture of the cervix before and after
the application of acetic acid. You will also have a clean probe, the size of a pencil,
placed against your cervix. The probe sends out light and reads how much light is absorbed
by the tissue. The reading will show doctors and nurses the types of molecules present in
the cells of the cervix. Two (2) to 3 measurements will be made. Each measurement takes
about a minute.
All participants will have routine visits every 6 months for 2 years. If you miss your
scheduled appointment, the next available appointment will be scheduled for you. At these
visits, study data will be collected. You will have a colposcopy and Pap smear. You will
have cervical biopsies taken and an ECC (if a high-grade lesion is seen). You will have
another HPV test.
If at your 24- month appointment there is a lesion on your cervix that can be seen by
colposcopy, you will be treated with a loop electrosurgical excision cone procedure. This is
a procedure where a tiny heated wire is used to remove the lesion from your cervix. If there
is no lesion on your cervix that can be seen by colposcopy, researchers will take 1 cervical
biopsy and an endocervical curettage.
You will be taken off study if the disease gets worse. You will be considered off study
after the 24-month visit.
This is an investigational study. The spectroscopy device has not been approved by the FDA.
It is authorized for use in research only. About 360 women will take part in this
multicenter study. Up to 120 women will be enrolled at UT MD Anderson Cancer Center.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)
A LEEP is unnecessary if histological examination results in diagnosis of low grade squamous intraepithelial lesion or normal. Comparison of 3 arms (colposcopy to colposcopy + spectroscopy, colposcopy + LEEP Procedure) in the diagnostic setting, stratifying participants by outside Papanicolaou (Pap) smear of low grade and high grade squamous intraepithelial lesions, and to use multispectral digital colposcopy retrospectively, in identifying unnecessary LEEPs performed.
Up to 2 years
Helen E. Rhodes, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Lyndon Baines Johnson General Hospital||Houston, Texas 77030|