Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
Recruitment status was: Not yet recruiting
RATIONALE: Studying Pap smears in the laboratory from women with atypical glandular cells of unspecified significance may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at Pap smears from women enrolled on clinical trial GOG-171.
Other: Papanicolaou test
Other: laboratory biomarker analysis
|Official Title:||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)|
- Presence of CIN-2 or CIN-3, significant glandular lesions (AIS), or invasive cancer as determined by the GOG Central Pathology Review of the loop electrosurgical excision procedure/large loop excision of the transformation zone tissue specimen [ Designated as safety issue: No ]
- Intensity of nuclear chromatin staining and chromatin distribution [ Designated as safety issue: No ]
- Distance between neighboring nuclei [ Designated as safety issue: No ]
- Nucleoli area to nucleus area ratio (N/N) [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
- 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 patients with a cytologic diagnosis of atypical glandular cells of unspecified significance (AGUS) to predict the presence of significant glandular lesions (i.e., adenocarcinoma in situ [AIS] or invasive cancer) and/or squamous lesions (i.e., cervical intraepithelial neoplasia [CIN2 or CIN3]) of the cervix.
- 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 patients with a cytologic diagnosis of AGUS to predict the presence of significant glandular lesions (i.e., AIS or invasive cancer) and/or squamous lesions (i.e., CIN2 or CIN3) of the cervix.
OUTLINE: Previously collected slides from Pap smears of patients enrolled on clinical trial GOG-171 are assessed for nuclear chromatin distribution, the shortest distances between the central points of neighboring cell nuclei, and nucleoli area/nucleus area (N/N) ratio via morphometric analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898144
|Study Chair:||Tsunehisa Kaku, MD||Kyushu University Hospital|
|OverallOfficial:||Keiichi Fujiwara, MD, PhD||Saitama Medical University International Medical Center|