Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
Primary Purpose
Cervical Cancer, Precancerous Condition
Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Papanicolaou test
laboratory biomarker analysis
Sponsored by
About this trial
This is an observational trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical adenocarcinoma, atypical squamous cells of undetermined significance
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
Sites / Locations
Outcomes
Primary Outcome Measures
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 Outcome Measures
Intensity of nuclear chromatin staining and chromatin distribution
Distance between neighboring nuclei
Nucleoli area to nucleus area ratio (N/N)
Full Information
NCT ID
NCT00898144
First Posted
May 9, 2009
Last Updated
November 5, 2010
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00898144
Brief Title
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
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Papanicolaou test
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Intensity of nuclear chromatin staining and chromatin distribution
Title
Distance between neighboring nuclei
Title
Nucleoli area to nucleus area ratio (N/N)
10. Eligibility
Sex
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsunehisa Kaku, MD
Organizational Affiliation
Kyushu University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Keiichi Fujiwara, MD, PhD
Organizational Affiliation
Saitama Medical University International Medical Center
12. IPD Sharing Statement
Learn more about this trial
Study of Pap Smears From Patients Enrolled on Clinical Trial GOG-171
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