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

Cervical Cancer Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00898144
• Other study ID #: CDR0000600575
• Secondary ID: GOG-8007
• Status: Not yet recruiting
• Phase: N/A
• First received: May 9, 2009
• Last updated: November 5, 2010
• Start date: February 2008

Study information

• Verified date: November 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Cervical Cancer
• Precancerous Condition
• Precancerous Conditions
• Uterine Cervical Neoplasms

Intervention

Other:
• Papanicolaou test

• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Secondary	Intensity of nuclear chromatin staining and chromatin distribution			No
Secondary	Distance between neighboring nuclei			No
Secondary	Nucleoli area to nucleus area ratio (N/N)			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database