Cervical DiseaseSpectralNCT02217215
Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies
An observational study of Cervical Disease, run by Guided Therapeutics at 1 site in United States.
Trial summary
The purpose 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 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Disease
- What is being tested?
- CNDS Advanced Cervical Scan
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Dec 2015
- 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 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: General screening population Scheduled for colposcopy
Who may be able to join
- Age 21 or above
- Able to read or understand and give informed consent
- Negative pregnancy test or documentation of acceptable birth control
- Willing to undergo colposcopy, cytology (if required) and HPV testing on day of study
- Abnormal cytology result within 120 days of CNDS test for Phase 2 subjects
Who cannot join
- Pregnancy
- Menstruating
- Previous cervical neoplasia
- Prior hysterectomy
- Conditions relating to the cervix that would render the test difficult to perform, including but not limited to:
- Excessive blood or mucus that cannot be removed Abnormal congenital cervix Unable to tolerate speculum or CNDS single use cervical guide
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Regents University
Augusta, Georgia, 30912
Daron G Ferris, MD, 706-721-2535, DFERRIS@gru.edu
Angela R Goebel, BS, 706 721-8944, agoebel@gru.edu
About this study
The purpose 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 the detailed description
Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with Cervical Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the Cervical Neoplasia Detection System (CNDS) test, a sample for Hybrid Capture 2 Human papillomavirus (HPV) testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.
A key component of effective screening studies designed to evaluate new detection modalities is verification of the gold standard comparison by which estimates of sensitivity and specificity are generated. In the case of screening studies in general and studies of cervical disease detection in particular, the avoidance of verification bias is a priority. For the purposes of the proposed study, CIN3 or cancer (CIN3+) must be verified or adjudicated by multiple histopathologists. Results for women with CIN1 or CIN2 will be confirmed histopathologically and analyzed as a separate subgroup because these lesions often regress to normal in certain populations and tend to cause disagreement among histopathologists. In order to verify absence of disease (i.e., CIN1 or less severe), the investigators will not rely on histopathology, as it would not be ethical to perform multiple biopsies or excisional procedures to obtain a tissue sample for histopathology. Instead, women will be considered normal if they have negative referral cytology, are free of high risk HPV and are colposcopically normal.
- Conditions
- Cervical Disease
- Being tested
- CNDS Advanced Cervical Scan
- Keywords
- Spectroscopy, HPV
- Medical subject headings
- Uterine Cervical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CNDS Advanced Cervical ScanDevice
Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Negative and Referral Cytology Results | CNDS Advanced Cervical Scan Colposcopy Receives: Device: CNDS Advanced Cervical Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy including sensitivity, specificity and predictive values
Collect clinical data for re-calibrating the processing of spectral data from the CNDS for eventual use as a primary screening modality. Resampling or other cross validation methods will be used to estimate the sensitivity, specificity and predictive values of a screening algorithm based on the recalibrated spectral data. These estimates will be used to compare with those of existing screening and diagnostic modalities such as Pap based cytopathology, HPV DNA testing and/or VIA (Visual Inspection with Acetic Acid).
Measured: for each participant approximately 30 days to collect data, no follow up data collected
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Is the CNDS safe when used as directed and that the test procedure is accepted by both physicians and their patients.
Measured: 30 days, no follow up inteneded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DiseaseStudies 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guided Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daron G Ferris, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217215
- Sponsor's protocol ID
- CLIN-4-CLP_0
- Acronym
- Spectral
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.
PubMed 23591399
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies
- ClinicalTrials.gov ID
- NCT02217215
- Acronym / sponsor ID
- Spectral / CLIN-4-CLP_0
- Conditions
- Cervical Disease
- Keywords
- Spectroscopy, HPV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Guided TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Aug 2014 (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 purpose 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.
Detailed description
Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with Cervical Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the Cervical Neoplasia Detection System (CNDS) test, a sample for Hybrid Capture 2 Human papillomavirus (HPV) testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.
A key component of effective screening studies designed to evaluate new detection modalities is verification of the gold standard comparison by which estimates of sensitivity and specificity are generated. In the case of screening studies in general and studies of cervical disease detection in particular, the avoidance of verification bias is a priority. For the purposes of the proposed study, CIN3 or cancer (CIN3+) must be verified or adjudicated by multiple histopathologists. Results for women with CIN1 or CIN2 will be confirmed histopathologically and analyzed as a separate subgroup because these lesions often regress to normal in certain populations and tend to cause disagreement among histopathologists. In order to verify absence of disease (i.e., CIN1 or less severe), the investigators will not rely on histopathology, as it would not be ethical to perform multiple biopsies or excisional procedures to obtain a tissue sample for histopathology. Instead, women will be considered normal if they have negative referral cytology, are free of high risk HPV and are colposcopically normal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Negative and Referral Cytology Results | – | Device: CNDS Advanced Cervical ScanCNDS Advanced Cervical Scan Colposcopy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General screening population Scheduled for colposcopy
Key inclusion criteria (5 listed)
- Age 21 or above
- Able to read or understand and give informed consent
- Negative pregnancy test or documentation of acceptable birth control
- Willing to undergo colposcopy, cytology (if required) and HPV testing on day of study
- Abnormal cytology result within 120 days of CNDS test for Phase 2 subjects
Key exclusion criteria (6 listed)
- Pregnancy
- Menstruating
- Previous cervical neoplasia
- Prior hysterectomy
- Conditions relating to the cervix that would render the test difficult to perform, including but not limited to:
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 |
|---|---|---|
| CNDS Advanced Cervical ScanSubjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated. | Device | Negative and Referral Cytology Results |
Primary outcome
Diagnostic accuracy including sensitivity, specificity and predictive values
Time frame: for each participant approximately 30 days to collect data, no follow up data collected
Collect clinical data for re-calibrating the processing of spectral data from the CNDS for eventual use as a primary screening modality. Resampling or other cross validation methods will be used to estimate the sensitivity, specificity and predictive values of a screening algorithm based on the recalibrated spectral data. These estimates will be used to compare with those of existing screening and diagnostic modalities such as Pap based cytopathology, HPV DNA testing and/or VIA (Visual Inspection with Acetic Acid).
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 30 days, no follow up inteneded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Results publication: PubMed 23591399Twiggs LB, Chakhtoura NA, Ferris DG, Flowers LC, Winter ML, Sternfeld DR, Lashgari M, Burnett AF, Raab SS, Wilkinson EJ. Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results. Gynecol Oncol. 2013 Jul;130(1):147-51. doi: 10.1016/j.ygyno.2013.04.012. Epub 2013 Apr 13.
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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.
Daron G Ferris, MD principal investigator
Augusta University
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 Disease, run by Guided Therapeutics 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daron G Ferris, MD (706 721-2535, DFERRIS@gru.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy including sensitivity, specificity and predictive values (time frame: for each participant approximately 30 days to collect data, no follow up data collected). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217215, which also lists 1 linked publication.
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 15 Aug 2014; AzTrials last refreshed its copy on 26 Oct 2026.