Comparative Analysis of biomarkers of cervical cells in Human Papillomavirus (HPV) in diagnosis of atypical glandular cells (AGC)

February 09, 2009
BH10-313
Cancer, Cancer-Gynecologic
Tashanna Myers, MD
  • D’Amour Center for Cancer Care, 3350 Main Street , Springfield, MA
  • Baystate Franklin Medical Center, 164 High Street, Greenfield, MA

The purpose of this study is to determine whether the presence of human papillomavirus (HPV) and certain chemical substances (biomarkers) in cervical cells can help identify which women with a cytologic diagnosis of AGC have a benign condition and which have a pre-cancerous condition or an invasive cancer that requires surgical removal. (This is a non-treatment study – specimen submission only).

Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Sampling Method: Non-Probability Sample

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

Recruiting
Observational
Laura Sorci
413-794-3188