Spectroscopy Versus Standard Care in Cervical Cancer Patients
Spectroscopy Versus Standard Care in Cervical Cancer Patients
Primary objectives

 1. To conduct a randomized clinical trial of the emerging technology fluorescence and
 reflectance spectroscopy, comparing colposcopy to colposcopy + spectroscopy in the
 diagnostic setting, stratifying patients by outside Papanicolaou (Pap) smear of low
 grade and high grade squamous intraepithelial lesions, and to use multispectral digital
 colposcopy retrospectively.

 The number of clinically read referral Paps, clinically read UT MD Anderson Cancer
 Center (MDACC) Paps, quantitatively read Paps, quantitatively read biopsies, point probe
 fluorescence/reflectance spectroscopy, and the multi-spectral digital colposcopy image,
 that shows a possible cancer, High-grade Squamous Intraepithelial Lesion (HGSIL),
 Low-grade Squamous Intraepithelial Lesion (LGSIL), or changes less than LGSIL to
 colposcopically directed biopsies at the first visit, Loop Electrical Excision Procedure
 (LEEP) at the second visit if needed, repeat evaluations at 6, 12, and 18 months that
 have Paps, or Paps + Endocervical Curettage or sample of the cervical canal + possible
 biopsy, and at the 24 month visit when all patients will at minimum have a Pap and an
 Endocervical Curettage for certain, and a cervical biopsy if any colposcopic abnormality
 is present.

 2. To see if optical spectroscopy using both the point probe and the multi-spectral device
 improves diagnosis by improving specificity over colposcopy alone.

 1. To study the number of colposcopically directed biopsies that show High-grade
 Squamous Intraepithelial or cancer.

 2. To study the number of LEEP specimens that show HGSIL or cancer.
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.
Inclusion Criteria:

 -  Patients 18 years and older

 -  Non-pregnant

 -  Patients with abnormal smears with cervical intraepithelial neoplasia (both low grade
 squamous intraepithelial lesions and high grade squamous intraepithelial lesions equal
 to cervical intraepithelial neoplasia 1-3)

 Exclusion Criteria:

 -  Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in
 this study, since the chemotherapy often induces change in the cervix.