Trials / Unknown
UnknownNCT00898144
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)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (estimated)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Papanicolaou test | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2009-06-01
- First posted
- 2009-05-12
- Last updated
- 2010-11-08
Source: ClinicalTrials.gov record NCT00898144. Inclusion in this directory is not an endorsement.