Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171 (NCT00898144)

Study 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.

Read the 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.

Conditions studied

Cervical Cancer
Precancerous Condition

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Keywords

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

In context

Uterine Cervical Neoplasms

1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.

This study's planned enrollment of 55 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Gynecologic Oncology Group is the lead sponsor of 181 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: Female
Accepts healthy volunteers: No

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

Study design

Enrollment: 55 participants (estimated)

Interventions

OtherPapanicolaou test
Otherlaboratory biomarker analysis

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00898144
Lead sponsor: Gynecologic Oncology Group
Collaborators: National Cancer Institute (NCI)
First posted: May 12, 2009
Start date: Feb 2008
Primary completion: Jun 2009 (estimated)
Last update: Nov 7, 2010

Study contacts

Tsunehisa Kaku, MD

study chair · Kyushu University Hospital

Keiichi Fujiwara, MD, PhD

Saitama Medical University International Medical Center

View the source record on ClinicalTrials.gov ↗

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