Cervical NeoplasiaNCT00766701
Spectroscopic Evaluation of Cervical Neoplasia
An observational study of Cervical Neoplasia, run by Guided Therapeutics at 7 sites in United States.
Trial summary
The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Cervical Neoplasia
- What is being tested?
- Procedure: Spectroscopy and Digital Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 1,599 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2003to Sep 2008
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Double-blind, Prospective, Safety-efficacy study
Who may be able to join
- Age 16 or above
- Able to read or understand and give informed consent
- Scheduled for colposcopy
- Pap test within 120 days
- Willing to undergo a Pap test and HPV test on day of study
Who cannot join
- Pregnancy
- Menstruating on the day of colposcopy and CNDS test
- Radiation therapy to her genitourinary system within 1 year
- Prior hysterectomy
- Congenital anatomical cervical variant (e.g., double cervix)
- Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma)
Show all 12Show fewer
- Post-coital or other significant bleeding at the time of the exam
- Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the investigator, to interfere with a Pap test or colposcopy, resulting from inflammatory, bacterial or other sources
- History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus).
- Undergoing phototherapy
- Recent use of photosensitizing agents, such as fluoroquinolones or retinoids).
- Patients who are pregnant are not eligible for this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Medical College of Georgia
Augusta, Georgia, 30912
University of Texas
Dallas, Texas, 75390
Saint Francis Hospital
Hartford, Connecticut, 06112
Orange Coast/Saddleback
Laguna Beach, California, 92653
University of Arkansas
Little Rock, Arkansas, 72205
University of Miami
Miami, Florida, 33136
About this study
Official title: Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix.
The specific aims of the study are:
- To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers.
- To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements.
- To evaluate the safety of spectroscopic measurement of cervical tissue.
Read the detailed description
If you agree to take part in this study, spectroscopic measurements on your cervix will be made for research purposes, prior to your routine colposcopy examination.
MEASUREMENT PROCEDURE:
The doctor will first place a vaginal speculum and then perform the LightTouch Ã'® procedure (that looks at tissue from the cervix using light). The doctor will use a fresh single use contact tube (a tube attached to the LightTouch device that helps hold it in place) and apply it gently to your cervix. This will transmit light much like a flashlight. The light will either reflect or bounce immediately off your cervix or it will enter the skin for less than a second, and then return back to the LightTouch device. Each reading will take about 5-7 minutes, and up to two readings may be taken. You may also be asked to repeat the experimental test the same day, for example 2 to 3 hours after the first test, as part of another experimental procedure to study whether the device gives the same result twice in a row on the same woman (a repeatability study). If you agree to a second (LightTouch) procedure you will again have placement of the contact tube applied gently to your cervix and another test will be taken. This could take another 5 to 7 minutes of your time.
Whether you agree to do one of the experimental tests or both of the tests, following the LightTouch experimental procedure(s), you will have a Pap smear of the endocervix (the doctor will use a small plastic brush remove cells from the endocervix canal). We will also test for human papilloma virus (HPV). HPV is a virus that is sexually transmitted is associated with abnormal Pap smears. The doctor will use two separate vials for these tests, one to take your Pap smear and the other to take more cells for an HPV test. Once the doctor takes your Pap smear and HPV test. The doctor will do the colposcopy exam using a colposcope to look at the cervix more closely to check for abnormal areas. The doctor will also apply acetic acid and Lugols if required. The doctor may also perform biopsy (remove one or more tissue samples you're your cervix) for later examination by a pathologist. If considered necessary, an ECC (Endocervical Curettage scraping of cells from the inside of the endocervix) will be performed if an abnormal area is seen.
A video image (camera) will be used to capture locations of abnormal areas and compare with the readings from the spectroscopic image. Your overall study participation time will be approximately 30 minutes. If you are asked to participate in second test and agree, it will take place directly after the first test. The spectroscopy portion in which measurements are taken takes 5 to 7 minutes to complete. If you have the second study procedure this will take an additional 15-30 minutes making your overall participation time up to 60 minutes (one hour). You may be asked to re-test one time during the same visit if the information collected is bad because of movement or if the device did not work.
The results of the LightTouch test will be compared with the results of your colposcopy and biopsy. The results of the LightTouch test test will not be used to plan your treatment. If your biopsy results show any abnormal changes, your doctor will discuss treatment options with you.
- Conditions
- Cervical Neoplasia
- Being tested
- Procedure: Spectroscopy and Digital Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Spectroscopy and Digital ImagingProcedure or surgery
Also called Spectroscopy, Digital Imaging
Procedure: Spectroscopy and Digital Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia.
Measured: December 2008
Secondary outcomes (1)
A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.
Measured: Q1 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startJan 2003
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guided Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Lisa Flowers, MD, Principal investigator, Emory University/Grady Hospital System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766701
- Sponsor's protocol ID
- GT1
- Status last verified
- Oct 2008
- First submitted
- 3 Oct 2008
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study for Assessment of Cervical Neoplasia Using Fluorescence and Reflectance Spectroscopy
- ClinicalTrials.gov ID
- NCT00766701
- Acronym / sponsor ID
- GT1
- Conditions
- Cervical Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,599 participants (actual)
- Lead sponsor
- Guided TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Oct 2008 (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 fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix.
The specific aims of the study are:
- To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers.
- To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements.
- To evaluate the safety of spectroscopic measurement of cervical tissue.
Detailed description
If you agree to take part in this study, spectroscopic measurements on your cervix will be made for research purposes, prior to your routine colposcopy examination.
MEASUREMENT PROCEDURE:
The doctor will first place a vaginal speculum and then perform the LightTouch Ã'® procedure (that looks at tissue from the cervix using light). The doctor will use a fresh single use contact tube (a tube attached to the LightTouch device that helps hold it in place) and apply it gently to your cervix. This will transmit light much like a flashlight. The light will either reflect or bounce immediately off your cervix or it will enter the skin for less than a second, and then return back to the LightTouch device. Each reading will take about 5-7 minutes, and up to two readings may be taken. You may also be asked to repeat the experimental test the same day, for example 2 to 3 hours after the first test, as part of another experimental procedure to study whether the device gives the same result twice in a row on the same woman (a repeatability study). If you agree to a second (LightTouch) procedure you will again have placement of the contact tube applied gently to your cervix and another test will be taken. This could take another 5 to 7 minutes of your time.
Whether you agree to do one of the experimental tests or both of the tests, following the LightTouch experimental procedure(s), you will have a Pap smear of the endocervix (the doctor will use a small plastic brush remove cells from the endocervix canal). We will also test for human papilloma virus (HPV). HPV is a virus that is sexually transmitted is associated with abnormal Pap smears. The doctor will use two separate vials for these tests, one to take your Pap smear and the other to take more cells for an HPV test. Once the doctor takes your Pap smear and HPV test. The doctor will do the colposcopy exam using a colposcope to look at the cervix more closely to check for abnormal areas. The doctor will also apply acetic acid and Lugols if required. The doctor may also perform biopsy (remove one or more tissue samples you're your cervix) for later examination by a pathologist. If considered necessary, an ECC (Endocervical Curettage scraping of cells from the inside of the endocervix) will be performed if an abnormal area is seen.
A video image (camera) will be used to capture locations of abnormal areas and compare with the readings from the spectroscopic image. Your overall study participation time will be approximately 30 minutes. If you are asked to participate in second test and agree, it will take place directly after the first test. The spectroscopy portion in which measurements are taken takes 5 to 7 minutes to complete. If you have the second study procedure this will take an additional 15-30 minutes making your overall participation time up to 60 minutes (one hour). You may be asked to re-test one time during the same visit if the information collected is bad because of movement or if the device did not work.
The results of the LightTouch test will be compared with the results of your colposcopy and biopsy. The results of the LightTouch test test will not be used to plan your treatment. If your biopsy results show any abnormal changes, your doctor will discuss treatment options with you.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Double-blind, Prospective, Safety-efficacy study
Key inclusion criteria (5 listed)
- Age 16 or above
- Able to read or understand and give informed consent
- Scheduled for colposcopy
- Pap test within 120 days
- Willing to undergo a Pap test and HPV test on day of study
Key exclusion criteria (12 listed)
- Pregnancy
- Menstruating on the day of colposcopy and CNDS test
- Radiation therapy to her genitourinary system within 1 year
- Prior hysterectomy
- Congenital anatomical cervical variant (e.g., double 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 |
|---|---|---|
| Procedure: Spectroscopy and Digital ImagingAlso: Spectroscopy, Digital ImagingProcedure: Spectroscopy and Digital Imaging | Procedure or surgery | – |
Primary outcome
Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia.
Time frame: December 2008
1 secondary outcome
A second objective is to prospectively demonstrate equivalence between two versions of the CNDS used in the pivotal trial.
Time frame: Q1 2009
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 6 Oct 2008.
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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.
Lisa Flowers, MD principal investigator
Emory University/Grady Hospital System
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Neoplasia, run by Guided Therapeutics at 7 sites 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 5 inclusion and 12 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 6 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 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?
Determine the efficacy of the CNDS, within the context of current ASCCP guidelines, to more effectively triage women with ASC/LSIL results, women with positive HPV results and women being followed for previous cervical dysplasia. (time frame: December 2008). 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 6 Oct 2008.