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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00898144
First received: May 9, 2009
Last updated: November 5, 2010
Last verified: November 2010

May 9, 2009
November 5, 2010
February 2008
June 2009   (final data collection date for primary outcome 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00898144 on ClinicalTrials.gov Archive Site
  • Intensity of nuclear chromatin staining and chromatin distribution [ Designated as safety issue: No ]
  • Distance between neighboring nuclei [ Designated as safety issue: No ]
  • Nucleoli area to nucleus area ratio (N/N) [ Designated as safety issue: No ]
Same as current
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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)

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.

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.

Observational
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  • Cervical Cancer
  • Precancerous Condition
  • Other: Papanicolaou test
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
55
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June 2009   (final data collection date for primary outcome measure)

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
Female
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No
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NCT00898144
CDR0000600575, GOG-8007
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Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Tsunehisa Kaku, MD Kyushu University Hospital
Investigator: Keiichi Fujiwara, MD, PhD Saitama Medical University International Medical Center
National Cancer Institute (NCI)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP