Last updated on March 2019

CA-IX p16 Proliferative Markers and HPV in Diagnosing Cervical Lesions in Patients With Abnormal Cervical Cells

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Human Papillomavirus Infection | Stage 0 Cervical Cancer AJCC v7 | Cervical Intraepithelial Neoplasia | Atypical Endocervical Glandular Cell of Undetermined Significance | Endometrial Hyperplasia
  • Age: Between 18 - 100 Years
  • Gender: Female

Inclusion Criteria:

  • Patients with a cytologic diagnosis of AGC (AGC, atypical endocervical cells [AEC], atypical endometrial cells [AEmC]) or a cytologic/histologic diagnosis of AIS documented within the last 6 months who can wait at least one week after the AGC or AIS diagnosis to have an LBC specimen (i.e., ThinPrep) collected and then receive any other intervention; acceptable time frame range is 4 days prior to registration to 7 days after registration
  • Patients with positive HPV results who are willing to undergo a complete histologic examination of the uterus and cervix, including the cervical transformation zone, within 6 months of the AGC or AIS diagnosis (histologic examination includes a loop electrosurgical excision procedure [LEEP], loop excision of the transformation zone [LETZ], excisional cone biopsy, or hysterectomy)
  • Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

  • Patients who have had a hysterectomy
  • History of endometrial hyperplasia or cancer of the endometrium, vagina, or cervix
  • Patients who have previously been treated, or are currently being treated with radiation therapy or chemotherapy for vaginal or cervical cancer
  • Patients who are known to be human immunodeficiency virus (HIV)-positive
  • Patients who are pregnant and thought to be at risk for excessive bleeding or preterm labor if a cone biopsy is performed

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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