Clinical trial NCT00898144: Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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

Primary outcomes:
measure: 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:
measure: Intensity of nuclear chromatin staining and chromatin distribution
measure: Distance between neighboring nuclei
measure: Nucleoli area to nucleus area ratio (N/N)
Other outcomes:
Locations:
Study officials:
affiliation: Kyushu University Hospital
name: Tsunehisa Kaku, MD
role: STUDY_CHAIR
affiliation: Saitama Medical University International Medical Center
name: Keiichi Fujiwara, MD, PhD
References: