Cervical CancerPhase 3NCT00529464
Spectroscopy Versus Standard Care in Cervical Cancer Patients
A Phase 3 study testing Fluorescence Spectroscopy, Colposcopy and LEEP Procedure in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Fluorescence Spectroscopy, Colposcopy and LEEP Procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in this study, since the chemotherapy often induces change in the cervix.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Lyndon Baines Johnson General Hospital
Houston, Texas, 77030
UT MD Anderson Cancer Center
Houston, Texas, 77030
Canada1 site
British Columbia Cancer Research Centre
Vancouver, British Columbia, V5Z 1L3
About this study
Official title: A Randomized Trial of Spectroscopy Versus Standard Care in Cervical Intraepithelial Neoplasia
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 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.
- To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone.
- To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer.
- To study the number of LEEP specimens that show HGSIL or cancer.
Read the detailed 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 UT MD Anderson Cancer Center.
- Conditions
- Cervical Cancer
- Being tested
- Fluorescence Spectroscopy, Colposcopy, LEEP Procedure
- Keywords
- Cervical Intraepithelial Neoplasia, Cervical Dysplasia, Cervical Cancer, Fluorescence Spectroscopy, Colposcopy, Loop Electrical Excision Procedure, LEEP
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence SpectroscopyProcedure or surgery
Pictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue.
ColposcopyProcedure or surgery
A standard colposcopy will be performed.
LEEP ProcedureProcedure or surgery
Also called Loop Electrical Excision Procedure
A small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam.
| Study group | Role | What they receive |
|---|---|---|
| Colposcopy | Experimental | Colposcopy - a direct magnified inspection of cervix Receives: Procedure: Colposcopy |
| Colposcopy + Fluorescence Spectroscopy | Experimental | Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample. Receives: Procedure: Fluorescence Spectroscopy; Procedure: Colposcopy |
| Colposcopy + LEEP Procedure | Experimental | Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue. Receives: Procedure: Colposcopy; Procedure: LEEP Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startNov 2006
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: Two participants enrolled, both inevaluable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Helen E. Rhodes, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529464
- Sponsor's protocol ID
- 2006-0582
- Status last verified
- Dec 2012
- First submitted
- 12 Sep 2007
- Last updated
- 9 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Spectroscopy Versus Standard Care in Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00529464
- Acronym / sponsor ID
- 2006-0582
- Conditions
- Cervical Cancer
- Keywords
- Cervical Intraepithelial Neoplasia, Cervical Dysplasia, Cervical Cancer, Fluorescence Spectroscopy, Colposcopy, Loop Electrical Excision Procedure, LEEP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Two participants enrolled, both inevaluable.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 8 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
- To see if optical spectroscopy using both the point probe and the multi-spectral device improves diagnosis by improving specificity over colposcopy alone.
- To study the number of colposcopically directed biopsies that show High-grade Squamous Intraepithelial or cancer.
- To study the number of LEEP specimens that show HGSIL or cancer.
Detailed 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 UT MD Anderson Cancer Center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Colposcopy | Experimental | Procedure: ColposcopyColposcopy - a direct magnified inspection of cervix |
| Colposcopy + Fluorescence Spectroscopy | Experimental | Procedure: Fluorescence Spectroscopy, Procedure: ColposcopyColposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample. |
| Colposcopy + LEEP Procedure | Experimental | Procedure: Colposcopy, Procedure: LEEP ProcedureColposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients who have had cytotoxic chemotherapy within 12-months prior to enrolling in this study, since the chemotherapy often induces change in the cervix.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence SpectroscopyPictures of the cervix will be taken before and after the application of acetic acid. A clean probe will be placed against the cervix that sends out light and reads how much light is absorbed by the tissue. | Procedure or surgery | Colposcopy + Fluorescence Spectroscopy |
| ColposcopyA standard colposcopy will be performed. | Procedure or surgery | Colposcopy, Colposcopy + Fluorescence Spectroscopy, Colposcopy + LEEP Procedure |
| LEEP ProcedureAlso: Loop Electrical Excision ProcedureA small heated wire loop is used to remove a cone-shaped piece of abnormal tissue. Procedure is performed on the same day as the colposcopy exam. | Procedure or surgery | Colposcopy + LEEP Procedure |
Primary outcome
Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP)
Time frame: Up to 2 years
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen E. Rhodes, MD principal investigator
M.D. Anderson Cancer Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluorescence Spectroscopy, Colposcopy and LEEP Procedure in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unnecessary Loop Electrosurgical Excision Procedures (LEEP) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.