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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
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 9, 2009
    Last Updated
    November 5, 2010
    Sponsor
    Gynecologic Oncology Group
    Collaborators
    National Cancer Institute (NCI)
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    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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