MORPHOMETRIC DIAGNOSIS OF ATYPICAL GLANDULAR LESIONS USING A CONVENTIONAL PAP SMEAR FROM GOG-0171 PATIENTS (ENROLLED BY GOG-JAPAN) WITH A CYTOLOGIC DIAGNOSIS OF ATYPICAL GLANDULAR CELLS OF UNSPECIFIED SIGNIFICANCE (AGUS)
Not Applicable
- Conditions
- AGUS
- Registration Number
- JPRN-UMIN000006760
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
Women who were not eligible and evaluable for the primary objective of GOG-0171, were not enrolled by GOG-JAPAN, or did not submit the original Pap smear used to define the cytological diagnosis of AGUS are not eligible for this protocol. Women or guardians who withdrew consent for GOG-0171 or who did not give permission to use her specimens for future cancer research in GOG-0171. When published on the website, in case there was opposition
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the diagnostic accuracy of using previously reported morphometric criteria for chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.
- Secondary Outcome Measures
Name Time Method To optimize the diagnostic accuracy of using chromatin distribution, shortest distance between nuclei and/or the ratio of nucleoli area to nucleus area in a conventional Pap smear from women with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (AIS or invasive cancer) and/or squamous lesions (CIN2 or CIN3) of the cervix.