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

NCT02217215 | Unknown

• 1 other identifier: CLIN-4-CLP_0
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Disease

Keywords

Spectroscopy; HPV

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  30 days, no follow up inteneded

Study Arms (1)

Negative and Referral Cytology Results

CNDS Advanced Cervical Scan Colposcopy

Device: CNDS Advanced Cervical Scan

Interventions

CNDS Advanced Cervical Scan DEVICE

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.

Negative and Referral Cytology Results

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General screening population Scheduled for colposcopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guided Therapeutics: lead

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• 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.

  PMID: 23591399 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

cells from the cervix to collect and test for HPV

MeSH Terms

Conditions

Uterine Cervical Diseases

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Daron G Ferris, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daron G Ferris, MD

CONTACT

706 721-2535; DFERRIS@gru.edu

Angela R Goebel, BS, CCRC

CONTACT

706 721-8944; agoebel@gru.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 15, 2014
• Study Start: August 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

US (1)