IMproved PRactice Outcomes and Value Excellence in Colposcopy
IMPROVE-COLPO
1 other identifier
observational
7,555
1 country
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2014
Typical duration for all trials
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 9, 2017
CompletedMarch 13, 2020
March 1, 2020
3.1 years
July 4, 2014
March 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects diagnosed with CIN2+ cervical lesions
Changes in number of subjects diagnosed with CIN2+ cervical lesions
At time of colposcopy
Study Arms (2)
Colposcopy with DySIS
The prospective arm will recruit patients referred for colposcopy and will be examined using DySIS.
Standard colposcopy
The retrospective arm will collect historical data from colposcopy examinations performed using a standard colposcope.
Interventions
Eligibility Criteria
Women referred for colposcopy after an abnormal screening test for prevention of cervical cancer
You may qualify if:
- Females 21 years or older
- Able to give informed consent
- 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
- x ASC-US cytology (25 or above)
- x/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
You may not qualify if:
- Previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer
- Pregnancy
- Known human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)
- Referred for vulva/vaginal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Arizona Oncology
Scottsdale, Arizona, 85258, United States
Unified Women's Clinical Research-Gainesville
Gainesville, Florida, 32605, United States
North Florida OB GYN Associates, PA
Jacksonville, Florida, 32216, United States
Osceola Ob-Gyn, PA
Kissimmee, Florida, 34741, United States
Unified Women's Clinical research-Alpharetta
Alpharetta, Georgia, 30005, United States
Unified Women's Clinical Research-Atlanta
Atlanta, Georgia, 30342, United States
Northeast Georgia Physicians Group- Heritage
Gainesville, Georgia, 30501, United States
Lakeside Ob/Gyn-Northeast Georgia Physician Group
Hoschton, Georgia, 30548, United States
Nye Partners in Women's Health
Chicago, Illinois, 60611, United States
Advocate Illinois Masonic Medical Center - Creticos Cancer Center
Chicago, Illinois, 60657, United States
Midwest Center for Women's Healthcare
Elgin, Illinois, 60123, United States
Advanced Women's Healthcare Specialists, SC
Elk Grove Village, Illinois, 60007, United States
Providea Health Partners, LLC
Evergreen Park, Illinois, 60805, United States
Women's Wellness World
Hazel Crest, Illinois, 60429, United States
Women's Healthcare of Illinois
Mokena, Illinois, 60448, United States
The Advanced Gynecologic Surgery Institute
Naperville, Illinois, 60540, United States
Women's Center for Health
Naperville, Illinois, 60540, United States
Southwest Women's Healthcare Associates
Olympia Fields, Illinois, 60461, United States
Hinsdale & Oak Brook Women's Clinic
Willowbrook, Illinois, 60527, United States
OB-GYN Associates
Cedar Rapids, Iowa, 52402, United States
Margaret A. Smollen, MD, PC
Iowa City, Iowa, 52245, United States
Brodsky & Taylor, PLC
Ferndale, Michigan, 48220, United States
Downriver Obstetrics & Gynecology
Trenton, Michigan, 48183, United States
NJ Gynecological Institute
Hackensack, New Jersey, 07601, United States
Women's Healthcare of Princeton, LLC
Princeton, New Jersey, 08540, United States
New Beginnings, OB/GYN
Springfield, New Jersey, 07081, United States
Dr Gregory Shifrin, OB/GYN, PC
Brooklyn, New York, 11229, United States
Unified Women's Clinical Research-Cary
Cary, North Carolina, 27518, United States
Unified Women's Clinical Research-Greensboro
Greensboro, North Carolina, 27401, United States
Unified Women's Clinical Research- Central Carolina
Greensboro, North Carolina, 27408, United States
Lyndhurst Clinical Research- Mt Airy
Mount Airy, North Carolina, 27030, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
The Women's Center at Southview
Dayton, Ohio, 45459, United States
Physicians & Surgeons for Women, Inc
Springfield, Ohio, 45505, United States
The University of Toledo
Toledo, Ohio, 43614, United States
Austin Area OB-Gyn
Austin, Texas, 78758, United States
Coastal Bend Women's center
Corpus Christi, Texas, 78412, United States
Laura Bradford, MD
Fort Worth, Texas, 76104, United States
Las Colinas OBGyn
Irving, Texas, 75062, United States
MacArthur OB/GYN
Irving, Texas, 75062, United States
Advanced Women's Wellness
Katy, Texas, 77450, United States
Zeid Women's Health Center
Longview, Texas, 75601, United States
Craig Ranch Ob/Gyn
McKinney, Texas, 75070, United States
Advanced Ob-Gyn Associates
Richardson, Texas, 75082, United States
Dr DeLeon's Women's Healthcare
Rowlett, Texas, 75088, United States
Piedmont Preferred Women's Healthcare Associates
Ridgeway, Virginia, 24148, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 9, 2014
Study Start
September 1, 2014
Primary Completion
October 9, 2017
Study Completion
October 9, 2017
Last Updated
March 13, 2020
Record last verified: 2020-03