Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

NCT00004091 | Completed

• 3 other identifiers: NU 99G3NU-99G3NCI-G99-1582
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment. PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

Conditions

Cervical Cancer

Keywords

cervical cancer

Interventions

Papanicolaou test OTHER

cytology specimen collection procedure OTHER

fluorescent antibody technique OTHER

colposcopic biopsy PROCEDURE

study of high risk factors PROCEDURE

Eligibility Criteria

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

Study Population

Patients must have a diagnosis of an abnormal Pap test, performed as part of standard of care screening in the clinic. The patient's informed consent will be obtained during their initial interview with the clinic physician.

DISEASE CHARACTERISTICS: Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Papanicolaou Test; Fluorescent Antibody Technique

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Phillip Y. Roland, MD

  Florida Gynecologic Oncology - Fort Myers

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: March 1, 2004
• Study Start: August 1, 1999
• Primary Completion: February 1, 2001
• Study Completion: February 1, 2001
• Last Updated: January 31, 2011

Record last verified: 2011-01

Locations

US (1)