Cervical CancerNCT00513123
Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
An observational study of Cervical Cancer, run by M.D. Anderson Cancer Center at 5 sites in 3 countries.
Trial summary
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 colposcopy for fluorescence spectroscopy. 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?
- Colposcopy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Sep 2002to Feb 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: Women 18 and older with an abnormal PAP.
Who may be able to join
- Women 18 and older with an abnormal Pap
Who cannot join
- Pregnant individuals will be excluded from this study
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 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: A Pilot Study: 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 colposcopy for fluorescence spectroscopy.
Other Objectives:
- To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
- To evaluate the effect of acetic acid in the image contrast obtained.
- Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.
Read the detailed description
DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).
DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.
- Conditions
- Cervical Cancer
- Being tested
- Colposcopy
- Keywords
- Digital Colposcopy for Fluorescence, DCF, Fluorescence Spectroscopy, Digital Colposcopy, DC, Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervix, Vagina, Lesions of the cervix, Precancerous lesions
- 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.
ColposcopyProcedure or surgery
As part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix.
| Study group | Role | What they receive |
|---|---|---|
| Digital Colposcopy | Digital Colposcopy for Fluorescence (DCF) Receives: Procedure: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.
Measured: 7 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startSep 2002
- Primary completionFeb 2009
- Study completionFeb 2009
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
- 100 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
- NCT00513123
- Sponsor's protocol ID
- GYN98-258
- Status last verified
- Jul 2012
- First submitted
- 7 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
- A Pilot Study: Measurement of Digital Colposcopy for Fluorescence Spectroscopy of Cervical Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00513123
- Acronym / sponsor ID
- GYN98-258
- Conditions
- Cervical Cancer
- Keywords
- Digital Colposcopy for Fluorescence, DCF, Fluorescence Spectroscopy, Digital Colposcopy, DC, Cervical Intraepithelial Neoplasia, Cervical Cancer, Cervix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 8 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 identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using digital colposcopy for colposcopy for fluorescence spectroscopy.
Other Objectives:
- To measure digital fluorescence and reflectance images in vivo of sites in the human cervix.
- To evaluate the effect of acetic acid in the image contrast obtained.
- Compare the device performance to colposcopy and pathologic analysis of tissue removed at colposcopy.
Detailed description
DCF may provide a better way to detect or treat lesions of the cervix. Women in the study will already be scheduled for colposcopy to detect or treat lesions of the cervix. (A colposcopy is an exam of the vagina and cervix using a magnifying lens).
DCF will be done during the routine colposcopy in the outpatient clinic. A digital colposcope (DC) device will be used to take a sequence of images of the cervix and vagina. (A DC is a digital camera connected to the colposcope with a specialized light source. It will shine light on the cervix and acquire a sequence images). The images will tell doctors about the cells and structure of the tissue. After the first set of images, acetic acid will be applied to the cervix so that lesions show up better, and 1-2 minutes later more readings will be taken.
Small samples of areas of abnormal tissue will be removed during colposcopy. Taking these tissue samples is a routine part of this type of exam. If patients are having colposcopy and loop electrosurgical excision procedure (LEEP treatment, one sample of normal tissue will be taken. (The cervix will be numbed for this procedure.) DCF images will be compared with lab findings from these samples. Before DCF is done, as standard of care, patients will have a complete history and physical exam, urine pregnancy test, pap smear, and cultures for gonorrhea, chlamydia and viral testing.
This is an investigational study. About 114 women will take part in this study. About 22 will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Colposcopy | – | Procedure: ColposcopyDigital Colposcopy for Fluorescence (DCF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women 18 and older with an abnormal PAP.
Key inclusion criteria (1 listed)
- Women 18 and older with an abnormal Pap
Key exclusion criteria (1 listed)
- Pregnant individuals will be excluded from 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 |
|---|---|---|
| ColposcopyAs part of routine colposcopic evaluation, patients will undergo routine colposcopy with the digital colposcope (DC) will then be used to take an image of the vagina and cervix. | Procedure or surgery | Digital Colposcopy |
Primary outcome
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions.
Time frame: 7 Years
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 Center websiteLink 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
5 sites in 3 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 5 sites in 3 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 1 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 5 sites in United States, Canada, Nigeria. 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?
To study whether digital colposcopy for fluorescence (DCF) can perform better than standard methods to detect cancer of the cervix or precancerous lesions. (time frame: 7 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 1 Aug 2012.