Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00898144

Enrollment

Registered

2009-05-12

Start date

2008-02-29

Completion date

Unknown

Last updated

2010-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Precancerous Condition

Keywords

cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical adenocarcinoma, atypical squamous cells of undetermined significance

Brief 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.

Interventions

OTHERPapanicolaou test

OTHERlaboratory biomarker analysis

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Intensity of nuclear chromatin staining and chromatin distribution	—
Distance between neighboring nuclei	—
Nucleoli area to nucleus area ratio (N/N)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026