Spectroscopy Versus Standard Care in Cervical Cancer Patients

21:48 EST 21st December 2014 | BioPortfolio

Summary

Primary Objectives:

- 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 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, Low-grade Squamous Intraepithelial Lesion, 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.

- 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.

Secondary Objectives:

- To measure the outcomes of health state in each patient in both arms of the trial.

- To measure the outcomes of efficacy using Receive Operating Characteristic curves and formal cost-effectiveness analyses of optical spectroscopy.

- To measure the efficacy of quantitative cytology and histopathology to see if ploidy, proliferation, and/or nuclear texture could predict LG progression or HG recurrence.

Description

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 M. D. Anderson.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cervical Cancer

Intervention

Fluorescence Spectroscopy, Colposcopy, LEEP Procedure

Location

U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Terminated

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Clinical Trials [709 Associated Clinical Trials listed on BioPortfolio]

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia

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 colposco...

Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears

RATIONALE: New diagnostic procedures such as fluorescence and reflectance spectroscopy (shining light on tissue and measuring patterns of light reflected) may improve the ability to noninv...

Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. PURPOSE: This clinical trial is studying digital colpo...

Digital Colposcopy in Finding Cervical Intraepithelial Neoplasia in Patients With An Abnormal Pap Smear

RATIONALE: Diagnostic procedures, such as digital colposcopy, may help doctors find and diagnose cervical intraepithelial neoplasia. PURPOSE: This clinical trial is studying digital colpo...

Measurement of Digital Colposcopy for Fluorescence Spectroscopy of TNC Using a Second Device

The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital Colposco...

PubMed Articles [23314 Associated PubMed Articles listed on BioPortfolio]

Does loop electrosurgical excision procedure of the uterine cervix affect anti-müllerian hormone levels?

Background. A delayed time to pregnancy was recently reported for women who had a loop electrosurgical excision procedure (LEEP) to remove cervical intraepithelial neoplasia (CIN) grade 2 or 3. The ob...

Advances in colposcopy: new technologies to challenge current practice.

Colposcopy has a poor sensitivity to detect precancerous abnormalities of the cervix. These abnormalities will become less common after HPV vaccinated girls enter the screened population. However HPV-...

Reduction of low- and high-grade cervical abnormalities associated with high uptake of the HPV bivalent vaccine in Scotland.

Background:In Scotland, a national HPV immunisation programme began in 2008 for 12- to 13-year olds, with a catch-up campaign from 2008 to 2011 for those under the age of 18. To monitor the impact of ...

A Comparison of 3 Ways of Conventional Pap Smear, Liquid-Based Cytology and Colposcopy vs Cervical Biopsy for Early Diagnosis of Premalignant Lesions or Cervical Cancer in Women with Abnormal Conventional Pap Test.

The most cost effective method of prevention and detection of cervical cancer is the Pap smear. In abnormal Pap smear, colposcopy, endocervical curettage and biopsy will be done. Gold standard method ...

Evaluation of diagnostic performances of visual cervical inspection with acetic Acid and colposcopy in benin city, Nigeria.

To determine the performance indicators of visual inspection with acetic acid (VIA) and colposcopy to detect cervical premalignant lesions.

Medical and Biotech [MESH] Definitions

A type of FLUORESCENCE SPECTROSCOPY using two FLUORESCENT DYES with overlapping emission and absorption spectra, which is used to indicate proximity of labeled molecules. This technique is useful for studying interactions of molecules and PROTEIN FOLDING.

Measurement of the intensity and quality of fluorescence.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

An analytical method for detecting and measuring FLUORESCENCE in compounds or targets such as cells, proteins, or nucleotides, or targets previously labeled with FLUORESCENCE AGENTS.

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