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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)


N/A
N/A
N/A
Not Enrolling
Female
Cervical Cancer, Precancerous Condition

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

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

Safety Issue:

No

Principal Investigator

Tsunehisa Kaku, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kyushu University Hospital

Authority:

Unspecified

Study ID:

CDR0000600575

NCT ID:

NCT00898144

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Precancerous Condition
  • cervical cancer
  • cervical intraepithelial neoplasia grade 2
  • cervical intraepithelial neoplasia grade 3
  • cervical adenocarcinoma
  • atypical squamous cells of undetermined significance
  • Uterine Cervical Neoplasms
  • Precancerous Conditions
  • Cervical Intraepithelial Neoplasia

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