Cervical CancerNCT00084903
Fluorescence and Reflectance Spectroscopy During Colposcopy in Detecting Cervical Intraepithelial Neoplasia and Dysplasia in Healthy Participants With a History of Normal Pap Smears
A study testing Colposcopic biopsy and Light-Scattering Spectroscopy in people with Cervical Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center at 2 sites in 2 countries.
Trial summary
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 noninvasively detect cervical intraepithelial neoplasia and dysplasia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- What is being tested?
- Colposcopic biopsy and Light-Scattering Spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,070 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 1998to Feb 2009
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
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
- 1) Pregnant individuals will be ineligible for this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
Canada1 site
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
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 noninvasively detect cervical intraepithelial neoplasia and dysplasia.
PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
Read the detailed description
OBJECTIVES:
- Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
- Determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix.
- Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
- Determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants.
- Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
- Conditions
- Cervical Cancer, Precancerous Condition
- Being tested
- Colposcopic biopsy, Light-Scattering Spectroscopy
- Keywords
- cervical cancer, cervical intraepithelial neoplasia
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colposcopic biopsyProcedure or surgery
Also called biopsy
Two small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings.
Light-Scattering SpectroscopyProcedure or surgery
Also called Spectroscopy, Fluorescence spectroscopy
Spectroscopy readings taken in 2 regions of cervix.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence Spectroscopy | Experimental | Not described Receives: Procedure: Colposcopic biopsy; Procedure: Light-Scattering Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent Measurements of Cervix
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
Measured: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startApr 1998
- Primary completionJul 2007
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,070 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 Rhodes, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084903
- Sponsor's protocol ID
- GYN97-244
- Other IDs
- P30CA016672, MDA-GYN-97244, UTHSC-HSC-MS-04-307, BCCA-RO2-1476, CDR0000366944
- Status last verified
- Aug 2012
- First submitted
- 10 Jun 2004
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathological Correlation of Colposcopically Directed Biopsies to Fluorescence EEM of the Normal Human Cervix
- ClinicalTrials.gov ID
- NCT00084903
- Acronym / sponsor ID
- GYN97-244
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, cervical intraepithelial neoplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,070 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1998
- Primary completion
- Jul 2007 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Jun 2004 (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.
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 noninvasively detect cervical intraepithelial neoplasia and dysplasia.
PURPOSE: This diagnostic trial is studying how well fluorescence and reflectance spectroscopy during colposcopy work in detecting cervical intraepithelial neoplasia and dysplasia in healthy participants with a history of normal Pap smears.
Detailed description
OBJECTIVES:
- Identify potential improvements in noninvasive methods of diagnosing dysplasia and neoplasia of the cervix using fluorescence and reflectance spectroscopy in healthy participants with a history of normal pap smears.
- Determine the reflection and fluorescence spectra of in vivo samples of the normal human cervix.
- Refine the detection of cervical lesions by fluorescence spectroscopy in these participants using improved classification of normal columnar tissue and non-neoplastic tissue with inflammation.
- Determine and validate the wavelength selections for spectroscopic diagnosis derived from in vitro measurements from these participants.
- Compare specific tissue sections from these participants with their excitation-emission matrices in order to identify the cell types contributing to the signal.
OUTLINE: Participants undergo placement of a fiber optic probe on one normal columnar cell site and one normal squamous cell site of the cervix during colposcopy*. The probe delivers laser light at a specific excitation wavelength and collects fluorescence from the entire emission wavelength range from the mucosa. Participants undergo biopsies of both sites.
NOTE: *The columnar epithelium will not be colposcopically visible in all patients, in which case 2 normal squamous sites will be measured
PROJECTED ACCRUAL: A total of 1,000 participants will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluorescence Spectroscopy | Experimental | Procedure: Colposcopic biopsy, Procedure: Light-Scattering Spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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)
- 1) 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 |
|---|---|---|
| Colposcopic biopsyAlso: biopsyTwo small samples of cervical tissue (biopsy) removed from 2 sites as spectroscopy readings. | Procedure or surgery | Fluorescence Spectroscopy |
| Light-Scattering SpectroscopyAlso: Spectroscopy, Fluorescence spectroscopySpectroscopy readings taken in 2 regions of cervix. | Procedure or surgery | Fluorescence Spectroscopy |
Primary outcome
Fluorescent Measurements of Cervix
Time frame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during colposcopy.
Two fluorescent measurements of cervix, approximately 2.5 minutes each: 1)colposcopically normal columnar site, and 2) a colposcopically normal squamous site.
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 2 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.
Helen Rhodes, MD study chair
M.D. Anderson Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colposcopic biopsy and Light-Scattering Spectroscopy in people with Cervical Cancer and Precancerous Condition, run by M.D. Anderson Cancer Center at 2 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 2 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 2 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?
Fluorescent Measurements of Cervix (time frame: Participation complete after readings of several 2.5 minutes fluorescent measurements and biopsies taken during 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 2 Aug 2012.