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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

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