Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies (Spectral)

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Disease
• Intervention / Treatment: Device: CNDS Advanced Cervical Scan

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Daron G Ferris, MD; Phone Number: 706 721-2535; Email: DFERRIS@gru.edu
• Study Contact Backup: Name: Angela R Goebel, BS, CCRC; Phone Number: 706 721-8944; Email: agoebel@gru.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
      • Contact: Daron G Ferris, MD; Phone Number: 706-721-2535; Email: DFERRIS@gru.edu
      • Contact: Angela R Goebel, BS; Phone Number: 706 721-8944; Email: agoebel@gru.edu
      • Principal Investigator: Daron G Ferris, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

General screening population Scheduled for colposcopy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Negative and Referral Cytology Results; CNDS Advanced Cervical Scan Colposcopy

Device: CNDS Advanced Cervical Scan; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	for each participant approximately 30 days to collect data, no follow up data collected

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days, no follow up inteneded

Collaborators and Investigators

• Sponsor: Guided Therapeutics
• Investigators: Principal Investigator: Daron G Ferris, MD, Augusta University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: August 5, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: HPV; Spectroscopy
• Additional Relevant MeSH Terms: Uterine Diseases; Uterine Cervical Diseases
• Other Study ID Numbers: CLIN-4-CLP_0