Cervical Cancer Clinical Trial
Official title:
Use of High-Resolution Microendoscopy (HRME) in Patients With Cervical Dysplasia
Verified date | May 2021 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this clinical research study is to compare a type of imaging called high-resolution microendoscopy (HRME) for detecting abnormal tissue in the cervix to the standard of care, which is visual inspection with acetic acid (VIA) with a colposcopy procedure. Researchers also want to learn if HRME images can show the difference between cancerous tissue and normal cervical tissue.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 14, 2021 |
Est. primary completion date | May 14, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. Women undergoing colposcopy for an abnormal Pap test, positive HPV test or history of cervical dysplasia (CIN or AIS) 2. Women of childbearing potential must have a negative pregnancy test 3. Women who are at least 21 years of age or older 4. Ability to understand and the willingness to provide informed consent and sign a written Informed Consent Document (ICD) Exclusion Criteria: 1. Women < 21 years of age 2. Women with a known allergy to proflavine or acriflavine 3. Women who are pregnant or nursing 4. Patients unable or unwilling to provide informed consent or sign a written Informed Consent Document (ICD) |
Country | Name | City | State |
---|---|---|---|
United States | Lyndon B. Johnson General Hospital | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance Between the Diagnosis Using HRME Imaging and the Most Severe Histologic Diagnosis ( Concordance rate monitored using method described by Thall et al. (1995)) | To evaluate the performance of HRME imaging compared with existing diagnostic techniques including colposcopy and visual inspection with acetic acid (VIA), a successful outcome is defined as concordance between the diagnosis using HRME imaging and the most severe histologic diagnosis. That is, researchers will calculate the concordance with the participant as the experimental unit rather than the biopsy, as each participant may have more than 1 biopsy. Target concordance rate is 70%. Concordance rate monitored using method described by Thall et al. (1995), and trial stopped if concordance rate is less than 70%. | 1 day |
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