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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003384 |
RATIONALE: The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.
PURPOSE: This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer.
Condition | Intervention |
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Cervical Cancer Precancerous/Nonmalignant Condition |
Other: laboratory biomarker analysis Procedure: biopsy Procedure: colposcopic biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Expression of the MN Protein in Atypical Glandular Cells of Undetermined Significance (Agus or Agcus) As a Potential Diagnostic Biomarker of Cervical Dysplasia/Neoplasia |
Estimated Enrollment: | 500 |
Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo a Pap smear followed by a ThinPrep cervical cell specimen collection at the time of direct colposcopic examination. Patients then undergo a cone biopsy of the cervix using loop electrosurgical excision procedure with an endocervical curettage, an excisional cone biopsy of the cervix with or without endocervical curettage, or a hysterectomy. Patients who are perimenopausal or postmenopausal or have a negative cervical cone biopsy also undergo endometrial biopsy or curettage. The Pap smear specimen is analyzed to determine MN antigen expression and the ThinPrep specimen is analyzed for the presence of high-risk human papilloma virus and to determine MN antigen and other marker (e.g., P16) expression.
Patients who do not undergo hysterectomy are followed every 6 months for 2 years. All other patients are followed at 4, 26, and 30 weeks.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study ID Numbers: | CDR0000066380, GOG-171 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003384 History of Changes |
Health Authority: | United States: Federal Government |
stage 0 cervical cancer precancerous/nonmalignant condition |
Genital Diseases, Female Uterine Cervical Diseases Precancerous Conditions Carcinoma in Situ Uterine Diseases |
Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |
Genital Diseases, Female Uterine Cervical Diseases Neoplasms Neoplasms by Histologic Type Precancerous Conditions Carcinoma in Situ |
Uterine Diseases Uterine Cervical Dysplasia Neoplasms, Glandular and Epithelial Carcinoma Cervical Intraepithelial Neoplasia |