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

NCT00898144 | Unknown

• 2 other identifiers: CDR0000600575GOG-8007
• Study Type: observational
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Intensity of nuclear chromatin staining and chromatin distribution

• Distance between neighboring nuclei

• Nucleoli area to nucleus area ratio (N/N)

Interventions

Papanicolaou test OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Precancerous Conditions; Uterine Cervical Dysplasia; Atypical Squamous Cells of the Cervix

Interventions

Papanicolaou Test

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tsunehisa Kaku, MD

  Kyushu University Hospital

  STUDY CHAIR

• Keiichi Fujiwara, MD, PhD

  Saitama Medical University International Medical Center

Study Design

• Study Type: observational
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Last Updated: November 8, 2010

Record last verified: 2010-11