High Grade Cervical Intraepithelial Neoplasia
Conditions
Keywords
colposcopy, CIN, cervical neoplasia, cervical dysplasia, cervical cancer, CIN2+
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.
Interventions
DEVICEDySIS
Colposcopy performed with the DySIS digital colposcope
Sponsors
DySIS Medical Inc.
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects diagnosed with CIN2+ cervical lesions | At time of colposcopy | Changes in number of subjects diagnosed with CIN2+ cervical lesions |
Countries
United States
Outcome results
None listed