Cervical CancerNCT00505726
Reflectance Confocal Imaging in Cervical Cancer Patients
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 4 sites in 2 countries.
Trial summary
The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions. Primary Objectives: 1. 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?
- Reflectance Confocal Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Nov 2001to Sep 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.
Who may be able to join
- Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
Who cannot join
- Pregnant individuals will be ineligible for this study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Lyndon B. Johnson Hospital
Houston, Texas, 77030
U. T. Health Science Center
Houston, Texas, 77030
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
Canada1 site
British Columbia Cancer Research Center
Vancouver, British Columbia
About this study
Official title: Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)
The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.
Primary Objectives:
- To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
- To obtain real time reflected light images in vivo of sites in the human cervix.
- To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
- Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
- Determine the sensitivity and specificity of this device for the diagnosis of CIN.
Read the detailed description
Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)
Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.
Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.
This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.
- Conditions
- Cervical Cancer
- Being tested
- Reflectance Confocal Imaging
- Keywords
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Reflectance Confocal Imaging, Colposcopy
- 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.
Reflectance Confocal ImagingProcedure or surgery
Microscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Confocal Microscopy | Not described Receives: Procedure: Reflectance Confocal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reflectance confocal images of cervical tissue in vivo
Measured: 1-2 minutes during routine colposcopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startNov 2001
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 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
- Michele Follen, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505726
- Sponsor's protocol ID
- ID01-555
- Other IDs
- CA82880
- Status last verified
- Jul 2012
- First submitted
- 20 Jul 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reflectance Confocal Imaging of Cervical Intraepithelial Neoplasia (CIN)
- ClinicalTrials.gov ID
- NCT00505726
- Acronym / sponsor ID
- ID01-555
- Conditions
- Cervical Cancer
- Keywords
- Cervical Intraepithelial Neoplasia, Cervical Cancer, Reflectance Confocal Imaging, Colposcopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2001
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to see if reflectance confocal microscopy works as well as standard methods to detect cancer of the cervix or precancerous lesions.
Primary Objectives:
- To identify potential clinical advantages for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using reflectance confocal microscopy.
- To obtain real time reflected light images in vivo of sites in the human cervix.
- To access the effects of acetic acid as a contrast agent for in vivo reflectance confocal imaging.
- Evaluate the depth of penetration for the fiber optic confocal device and analyze the diagnostic value of images taken from different depths.
- Determine the sensitivity and specificity of this device for the diagnosis of CIN.
Detailed description
Confocal microscopy may be a new way to detect lesions of the cervix quickly without removing a tissue sample. Women in the study will already be scheduled for colposcopy to detect or treat cervical lesions. (A colposcopy is an exam of the vagina and cervix using a magnifying lens.)
Microscopic images will be taken during the routine colposcopy in the outpatient clinic. A disinfected probe will be inserted into the vagina and placed against the cervix. . The probe sends out laser light and detects reflected light from the tissue. Images of cervical tissue will be formed and displayed on a computer monitor. 1-3 regions of the cervix will be imaged (2 abnormal and one normal), and each will take about 1-2 minutes.
Each imaged site will be biopsied. The biopsies will be analyzed by the research pathologist. The results will be available to participants in the event that care needs to be given. Total participation in this study will be only a few minutes.
This is an investigational study. About 72 women will take part in this study. About 18 will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal Microscopy | – | Procedure: Reflectance Confocal Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, 18 years of age or older, who are already scheduled for colposcopy to detect or treat cervical lesions.
Key inclusion criteria (2 listed)
- Subjects will be individuals 18 years of age or older, who have voluntarily responded to advertisement in the form of posted flyers or word of mouth.
- Subjects must sign an informed consent indicating awareness of the investigational nature of this study.
Key exclusion criteria (1 listed)
- Pregnant individuals will be ineligible for this study.
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 |
|---|---|---|
| Reflectance Confocal ImagingMicroscopic images taken during routine colposcopy where disinfected probe inserted into vagina and placed against cervix, 1-3 regions imaged (2 abnormal and one normal), and each taking about 1-2 minutes. | Procedure or surgery | Confocal Microscopy |
Primary outcome
Reflectance confocal images of cervical tissue in vivo
Time frame: 1-2 minutes during routine colposcopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- UT 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.
Michele Follen, MD, PhD principal investigator
M.D. Anderson Cancer Center
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 4 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 2 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: finished, as of the sponsor's last update on 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reflectance confocal images of cervical tissue in vivo (time frame: 1-2 minutes during routine colposcopy). 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 1 Aug 2012.