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Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003384
First received: November 1, 1999
Last updated: April 12, 2011
Last verified: October 2005
  Purpose

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
Cervical Cancer
Precancerous Condition
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: colposcopic biopsy

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • None specified [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 1998
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Evaluate the utility of MN protein, a novel tumor-associated antigen, as a potential diagnostic biomarker for cervical glandular and/or squamous neoplasia in patients with a cytologic diagnosis of atypical glandular cells of undetermined significance (AGUS).
  • Measure the frequency and type of cervical pathology associated with the diagnosis of AGUS in these patients.
  • Determine whether the presence of a high-risk type of human papilloma virus (HPV) in a ThinPrep cervical cell specimen predicts the presence of cervical glandular and/or squamous cell neoplasia in these patients.
  • Determine the relationship between MN antigen expression and the presence of high-risk HPV in these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Cytologically confirmed atypical glandular cells of undetermined significance (AGUS)
  • Must be scheduled to undergo complete histologic examination of the cervix by cone biopsy using loop electrosurgical excision procedure with an endocervical curettage, excisional cone biopsy with or without endocervical curettage, or hysterectomy within 6 months of the initial cytologic diagnosis of AGUS
  • No history of endometrial hyperplasia
  • No history of cancer of the endometrium, vagina, or cervix

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • HIV negative
  • No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy for vaginal and/or cervical cancer

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the vagina or cervix
  • No concurrent radiotherapy to the vagina or cervix

Surgery

  • See Disease Characteristics
  • No prior hysterectomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003384

Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Shu-Yuan Liao St. Joseph Hospital Regional Cancer Center - Orange
  More Information

Additional Information:
Publications:
Liao SY, Rodgers WH, Bonfiglio T, et al.: Carbonic anhydrase IX (CAIX) and human papillomavirus (HPV) as potential diagnostic biomarkers of cervical dysplasia/neoplasia in women with a cytologic diagnosis of atypical glandular cells of undetermined significance (AGUS): a Gynecologic Oncology Group (GOG) study. [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-321, 2007.

ClinicalTrials.gov Identifier: NCT00003384     History of Changes
Other Study ID Numbers: CDR0000066380, GOG-0171
Study First Received: November 1, 1999
Last Updated: April 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage 0 cervical cancer
precancerous condition

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Precancerous Conditions
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Carcinoma
Carcinoma in Situ
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014