Clinical trial NCT02217215: Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies
Official title: Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Disease
Keywords: Spectroscopy
HPV
Lead sponsor: Guided Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 800
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General screening population Scheduled for colposcopy

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diagnostic accuracy including sensitivity, specificity and predictive values
timeFrame: for each participant approximately 30 days to collect data, no follow up data collected
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 30 days, no follow up inteneded
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
Study officials:
affiliation: Augusta University
name: Daron G Ferris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.