Clinical trial NCT02185599: IMproved PRactice Outcomes and Value Excellence in Colposcopy
Official title: IMproved PRactice Outcomes and Value Excellence in Colposcopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Grade Cervical Intraepithelial Neoplasia
Keywords: colposcopy
CIN
cervical neoplasia
cervical dysplasia
cervical cancer
CIN2+
Lead sponsor: DySIS Medical Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 7555
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer

Brief summary: The study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the DySIS colposcope with Advanced Cervical Scan.

The study will collect colposcopy data across multiple sites in two arms; a prospective arm, with DySIS being used for the examination and a retrospective arm, with data retrieved from patient charts.

Detailed description: Each site will contribute data to both arms; the study will collect data on demographics, disease yield, number of biopsies and treatment decisions. Study subjects will receive standard of care procedures and management.

Prospective data will be collected at colposcopy examinations performed using the DySIS digital colposcope on consecutive patients that have been referred for colposcopy after a positive screening test. Retrospective data on colposcopy examinations performed using a standard colposcope will be collected from patient medical records, to capture standard practice to-date as a control for comparisons. The retrospective data will be collected from consecutive examinations performed by the providers participating in the prospective arm and for the preceding year.

Eligibility criteria: Inclusion Criteria:

1. Females 21 years or older
2. Able to give informed consent
3. Referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice:

   * HSIL, ASC-H, LSIL cytology
   * 2x ASC-US cytology (25 or above)
   * 2x/3x LSIL/ASC-US cytology (21-24)
   * ASC-US pap and hrHPV cotest/reflex
   * HPV 16/18 primary screening (≥25)
   * ASC-US pap after hrHPV
   * hrHPV x2 (≥30)
   * HPV16 or 16 after negative cytology/hrHPV (≥30)
   * Follow-up of CIN2/3 biopsy (younger women)
   * hrHPV and/or ≥ASC-US pap post-excision

Exclusion Criteria:

1. Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
2. Pregnancy
3. Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
4. Referred for vulva/vaginal disease

Primary outcomes:
measure: Number of subjects diagnosed with CIN2+ cervical lesions
timeFrame: At time of colposcopy
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Oncology
state: Arizona
city: Gainesville
country: United States
facility: Unified Women's Clinical Research-Gainesville
state: Florida
city: Jacksonville
country: United States
facility: North Florida OB GYN Associates, PA
state: Florida
city: Kissimmee
country: United States
facility: Osceola Ob-Gyn, PA
state: Florida
city: Alpharetta
country: United States
facility: Unified Women's Clinical research-Alpharetta
state: Georgia
city: Atlanta
country: United States
facility: Unified Women's Clinical Research-Atlanta
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Physicians Group- Heritage
state: Georgia
city: Hoschton
country: United States
facility: Lakeside Ob/Gyn-Northeast Georgia Physician Group
state: Georgia
city: Chicago
country: United States
facility: Nye Partners in Women's Health
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center - Creticos Cancer Center
state: Illinois
city: Elgin
country: United States
facility: Midwest Center for Women's Healthcare
state: Illinois
city: Elk Grove Village
country: United States
facility: Advanced Women's Healthcare Specialists, SC
state: Illinois
city: Evergreen Park
country: United States
facility: Providea Health Partners, LLC
state: Illinois
city: Hazel Crest
country: United States
facility: Women's Wellness World
state: Illinois
city: Mokena
country: United States
facility: Women's Healthcare of Illinois
state: Illinois
city: Naperville
country: United States
facility: The Advanced Gynecologic Surgery Institute
state: Illinois
city: Naperville
country: United States
facility: Women's Center for Health
state: Illinois
city: Olympia Fields
country: United States
facility: Southwest Women's Healthcare Associates
state: Illinois
city: Willowbrook
country: United States
facility: Hinsdale & Oak Brook Women's Clinic
state: Illinois
city: Cedar Rapids
country: United States
facility: OB-GYN Associates
state: Iowa
city: Iowa City
country: United States
facility: Margaret A. Smollen, MD, PC
state: Iowa
city: Ferndale
country: United States
facility: Brodsky & Taylor, PLC
state: Michigan
city: Trenton
country: United States
facility: Downriver Obstetrics & Gynecology
state: Michigan
city: Hackensack
country: United States
facility: NJ Gynecological Institute
state: New Jersey
city: Princeton
country: United States
facility: Women's Healthcare of Princeton, LLC
state: New Jersey
city: Springfield
country: United States
facility: New Beginnings, OB/GYN
state: New Jersey
city: Brooklyn
country: United States
facility: Dr Gregory Shifrin, OB/GYN, PC
state: New York
city: Cary
country: United States
facility: Unified Women's Clinical Research-Cary
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research-Greensboro
state: North Carolina
city: Greensboro
country: United States
facility: Unified Women's Clinical Research- Central Carolina
state: North Carolina
city: Mount Airy
country: United States
facility: Lyndhurst Clinical Research- Mt Airy
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Dayton
country: United States
facility: The Women's Center at Southview
state: Ohio
city: Springfield
country: United States
facility: Physicians & Surgeons for Women, Inc
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
city: Austin
country: United States
facility: Austin Area OB-Gyn
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Women's center
state: Texas
city: Fort Worth
country: United States
facility: Laura Bradford, MD
state: Texas
city: Irving
country: United States
facility: Las Colinas OBGyn
state: Texas
city: Irving
country: United States
facility: MacArthur OB/GYN
state: Texas
city: Katy
country: United States
facility: Advanced Women's Wellness
state: Texas
city: Longview
country: United States
facility: Zeid Women's Health Center
state: Texas
city: McKinney
country: United States
facility: Craig Ranch Ob/Gyn
state: Texas
city: Richardson
country: United States
facility: Advanced Ob-Gyn Associates
state: Texas
city: Rowlett
country: United States
facility: Dr DeLeon's Women's Healthcare
state: Texas
city: Ridgeway
country: United States
facility: Piedmont Preferred Women's Healthcare Associates
state: Virginia
Study officials:
References: