Cervical DysplasiaNCT00511758
Digital Imaging Aid for Assessment of Cervical Dysplasia
An observational study of Cervical Dysplasia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix. The specific aims of the study are: To compare polarized and green filtered digital images of the cervix, to standard white light images… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- Digital Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to May 2009
- 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: Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Who may be able to join
- Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
- Patients must sign an informed consent indicating awareness of the investigational nature of this study.
Who cannot join
- Patients who are pregnant are not eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
The overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.
The specific aims of the study are:
- To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
- To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
Read the detailed description
If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.
VISUAL DETECTION OF PRECANCEROUS LESIONS:
Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.
STUDY PARTICIPATION:
You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.
Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.
Researchers will use these images to make comparison studies with the colposcopy procedure.
LENGTH OF STUDY:
Your participation will be finished on this study once your cervix has been examined with the digital camera.
This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Cervical Dysplasia
- Being tested
- Digital Imaging
- Keywords
- Cervical Dysplasia, Digital Imaging, Colposcopy, Cervix
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital ImagingProcedure or surgery
Images of the cervix will be taken using different types of light and compared with the colposcopy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Digital Imaging Device | Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy. Receives: Procedure: Digital Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJun 2007
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: Low accrual rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies 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
- 3 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
- NCT00511758
- Sponsor's protocol ID
- 2007-0230
- Status last verified
- Jul 2012
- First submitted
- 2 Aug 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
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
- Pilot Study of a Digital Imaging Aid for Assessment of Cervical Dysplasia
- ClinicalTrials.gov ID
- NCT00511758
- Acronym / sponsor ID
- 2007-0230
- Conditions
- Cervical Dysplasia
- Keywords
- Cervical Dysplasia, Digital Imaging, Colposcopy, Cervix
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual rate.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Aug 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 overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix.
The specific aims of the study are:
- To compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue.
- To develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix.
- To analyze digital images to determine which types of optical information yield the most diagnostically useful data.
Detailed description
If you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix.
VISUAL DETECTION OF PRECANCEROUS LESIONS:
Reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. Researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue.
STUDY PARTICIPATION:
You will be seen in the clinic during a routine visit. Your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded.
Your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). These digital images will be taken before and after acetic acid (vinegar) is applied.
Researchers will use these images to make comparison studies with the colposcopy procedure.
LENGTH OF STUDY:
Your participation will be finished on this study once your cervix has been examined with the digital camera.
This is an investigational study. Up to patients 20 will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Imaging Device | – | Procedure: Digital ImagingPatients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of cervical dysplasia that are scheduled for a colposcopy.
Key inclusion criteria (2 listed)
- Patients 18 years or older who are referred to the University of Texas MD Anderson Cancer Center Colposcopy Clinic for colposcopy are eligible for this study.
- Patients must sign an informed consent indicating awareness of the investigational nature of this study.
Key exclusion criteria (1 listed)
- Patients who are pregnant are not eligible 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 |
|---|---|---|
| Digital ImagingImages of the cervix will be taken using different types of light and compared with the colposcopy procedure. | Procedure or surgery | Digital Imaging Device |
Primary outcome
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue.
Time frame: 2 Year
Results and safety
The study was stopped early (reason given: Low accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2012.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Dysplasia, run by M.D. Anderson Cancer Center at 1 site in United States.
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: stopped early, 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 1 site in United States. 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 was stopped early (reason given: Low accrual rate.). Results are not available in the source record.
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?
Evaluate whether a digital camera image can work as well as colposcopy at detecting precancerous tissue. (time frame: 2 Year). 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.