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Trial Title:
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
NCT ID:
NCT00898144
Condition:
Cervical Cancer
Precancerous Condition
Conditions: Official terms:
Uterine Cervical Neoplasms
Precancerous Conditions
Conditions: Keywords:
cervical cancer
cervical intraepithelial neoplasia grade 2
cervical intraepithelial neoplasia grade 3
cervical adenocarcinoma
atypical squamous cells of undetermined significance
Study type:
Observational
Overall status:
Unknown status
Intervention:
Intervention type:
Other
Intervention name:
Papanicolaou test
Intervention type:
Other
Intervention name:
laboratory biomarker analysis
Summary:
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.
Detailed description:
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Criteria for eligibility:
Criteria:
DISEASE CHARACTERISTICS:
- Cytologically confirmed atypical glandular cells of unspecified significance
- Original Pap smear used to define the diagnosis must be available for review
- Previously enrolled by GOG-JAPAN onto clinical trialGOG-171
- Must have been eligible and evaluable for the primary objective of GOG-171
- Gave permission to use specimens for future cancer research in GOG-171
- Underwent a loop electrosurgical excision procedure/large loop excision of the
transformation zone (LEEP/LLETZ) procedure on clinical trial GOG-171 to determine the
presence of cervical intraepithelial neoplasia (CIN-2 or CIN-3), significant glandular
lesions (AIS), or invasive cancer
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 2008
Lead sponsor:
Agency:
Gynecologic Oncology Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on April 01, 2022
ClinicalTrials.gov page:
https://clinicaltrials.gov/show/NCT00898144
