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

Completed · Not applicable

Conditions studied: Precancerous Condition, Stage 0 Cervical Cancer

In brief

This diagnostic trial is studying the presence of a specific protein as a potential biomarker of cervical dysplasia and/or cancer. The presence of specific proteins may allow a doctor to determine whether a patient has cervical dysplasia and/or cancer.

Key facts

Study ID

NCT00003384

Run by

Gynecologic Oncology Group

People needed

684

Starts

1998-09-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• HIV negative
• No pregnant patients who are at high risk for excessive bleeding or preterm labor if a cone biopsy is performed
• No prior cytotoxic chemotherapy for vaginal and/or cervical cancer
• No prior radiotherapy to the vagina or cervix
• No concurrent radiotherapy to the vagina or cervix
• No prior hysterectomy

Where it is running

• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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