Amy L Mitchell

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• Garcia, F. A., Mitchell, A. L., Alberts, D. S., Byron, J. W., Chow, S., Cornelison, T. L., Greenspan, D. L., Hsu, C. H., & Nuno, T. (2013). Abstract C50: Results of a phase II randomized, double-blind, placebo controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia. Cancer Prevention Research, 6(11_Supplement), C50-C50. doi:10.1158/1940-6215.prev-13-c50
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  In vitro data and pilot clinical trial data suggest that green tea catechins may possess chemopreventive activity for cervical cancer and its precursor lesions. We conducted a randomized, double-blind, placebo controlled trial of Polyphenon E (decaffeinated and enriched green tea catechin extract) in women with persistent human papillomavirus (HPV) infection and low grade cervical intraepithelial neoplasia (CIN1) to evaluate the potentials of Polyphenon E for cervical cancer prevention. Ninety-eight eligible women were randomized to receive either Polyphenon E (containing 800 mg epigallocatechin gallate) or placebo once daily for 4 months. The primary study outcome was oncogenic HPV clearance and clearance of CIN1. Polyphenon E was shown to be acceptable, safe and well tolerated. There was no difference in the response rate by treatment allocation. Complete response, defined as negative for high risk HPV and normal histopathology, was noted in 7 (17.1%) and 6 (14.6%) women in the Polyphenon E and placebo arms, respectively. Partial response, defined as clearance of oncogenic HPV with evidence of CIN1, occurred more frequently in the placebo group 6 (14.6%) vs. 1 (2.4%) in the Polyphenon E arm. Progression, defined as persistent oncogenic HPV with histopathologic evidence of progression, was more common in the Polyphenon E group [3 (7.7%) vs. 6 (14.6%) in the placebo arm, although neither of these observations were statistically significant. Based on the largest randomized placebo-controlled trial of a green tea extract for HPV related cervical disease, we conclude that four months of Polyphenon E intervention did not promote the clearance of persistent high risk HPV and related CIN 1. Further studies may be necessary to better delineate the risk factors for persistent HPV infection and biology of the disease to facilitate the evaluation of chemopreventive strategies. Citation Format: Tomas Nuno, Francisco A.R. Garcia, Terri Cornelison, Amy L. Mitchell, David L. Greenspan, John W. Byron, Chiu-Hsieh Hsu, David S. Alberts, Sherry Chow. Results of a phase II randomized, double-blind, placebo controlled trial of Polyphenon E in women with persistent high-risk HPV infection and low-grade cervical intraepithelial neoplasia. [abstract]. In: Proceedings of the Twelfth Annual AACR International Conference on Frontiers in Cancer Prevention Research; 2013 Oct 27-30; National Harbor, MD. Philadelphia (PA): AACR; Can Prev Res 2013;6(11 Suppl): Abstract nr C50.
• Abalos, A. T., Harris, R. B., Nyitray, A. G., Thompson, P. A., Giuliano, A. R., Garcia, F. A., & Mitchell, A. L. (2012). Human papillomavirus type distribution among heterosexual couples.. Journal of lower genital tract disease, 16(1), 10-5. doi:10.1097/lgt.0b013e31822a8404
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  To gain a better understanding of human papillomavirus (HPV) transmission dynamics between sexual partners, HPV-type-specific concordance was investigated..Twenty-nine couples were enrolled in this cross-sectional study. Mean age was 30.5 years (range = 19.1-42.6 y) for men and 28.2 years (range = 19.4-44.5 y) for women. Samples were collected at the glans penis, penile shaft, and scrotum in men and at the endo/ectocervix and labia/vulva, and perineum in women. Samples were analyzed for the presence of HPV DNA first by polymerase chain reaction and then genotyped using the reverse-line blot method..Human papillomavirus prevalence for any HPV type was 75.9% among men and 86.2% among women. Eleven men and 10 women were infected with multiple HPV types. At least partial type-specific concordance was observed in 66% of the couples. Forty-one percent of the couples had perfect concordance. In 11 couples (37.9%), complete discordance was observed..These results provide valuable information about HPV-type-specific concordance and demonstrate the complexity of transmission dynamics in heterosexual couples.
• Einstein, M. H., Garcia, F. A., Mitchell, A. L., & Day, S. P. (2011). Age-stratified performance of the Cervista HPV 16/18 genotyping test in women with ASC-US cytology.. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 20(6), 1185-9. doi:10.1158/1055-9965.epi-11-0116
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  The objective of this study was to evaluate the clinical performance of the Cervista HPV 16/18 genotyping test for detection of human papilloma virus (HPV) 16 and 18 in cervical cytology specimens in women stratified by age..In a multicenter, prospective clinical study, ThinPrep specimens were tested for the presence of HPV 16 and 18 using the HPV 16/18 genotyping test. Genotyping results from women with atypical squamous cells of undetermined significance or greater cytology were compared with local colposcopy and/or histology results. Sensitivity, specificity, and negative and positive predictive values (NPV and PPV) were determined..The prevalence of cervical intraepithelial neoplasia (CIN) 2(+) in subjects positive for HPV 16/18 was 6.6% and 4.1% for women
• Einstein, M. H., Martens, M. G., Garcia, F. A., Ferris, D. G., Mitchell, A. L., Day, S. P., & Olson, M. C. (2011). Clinical validation of the cervista HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology. Obstetrical & Gynecological Survey, 66(4), 211-212. doi:10.1097/ogx.0b013e318225cd2e
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  Abstract Objective High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista® HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens. Methods The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel. Results There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1–96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1–99.6). Sensitivity for detection of ≥CIN 3 in women with ASC-US was 100% (95% CI: 85.1–100) and the NPV was 100% (95% CI: 99.4–100). The specificity of the test for detection of ≥CIN 2 and ≥CIN 3 was 44.2% (95% CI: 41.5–46.9) and 43% (95% CI: 40.3–45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV. Conclusion The Cervista® HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.
• Einstein, M. H., Martens, M. G., Garcia, F. A., Ferris, D. G., Mitchell, A. L., Day, S. P., & Olson, M. C. (2010). Clinical validation of the Cervista HPV HR and 16/18 genotyping tests for use in women with ASC-US cytology.. Gynecologic oncology, 118(2), 116-22. doi:10.1016/j.ygyno.2010.04.013
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  High-risk (HR) human papillomavirus (HPV) testing is important in cervical cancer screening for triage to colposcopy. This study evaluated the clinical performance of the Cervista HPV HR and 16/18 genotyping tests for detection of HPV in cervical cytology specimens..The tests were prospectively evaluated in a multicenter clinical study. DNA was extracted from approximately 4000 residual liquid-based cytology specimens collected during routine liquid-based Papanicolaou tests at standard of care visits and was assessed for the presence of HR HPV and/or HPV types 16 and 18. All women with cytology results of atypical squamous cells of undetermined significance (ASC-US) or greater underwent colposcopic examination and biopsies were collected. Test results were compared with local colposcopy and histology results from a central pathology review panel..There were 1347 subjects with complete data sets of cytology, HR HPV, colposcopy, and histology included in the analysis of the HPV HR test. Sensitivity of the HPV HR test for detection of cervical intraepithelial neoplasia (CIN) 2+ among women with ASC-US cytology was 92.8% (95% confidence interval [CI]: 84.1-96.9) and the negative predictive value (NPV) was 99.1% (95% CI: 98.1-99.6). Sensitivity for detection of > or =CIN 3 in women with ASC-US was 100% (95% CI: 85.1-100) and the NPV was 100% (95% CI: 99.4-100). The specificity of the test for detection of > or =CIN 2 and > or =CIN 3 was 44.2% (95% CI: 41.5-46.9) and 43% (95% CI: 40.3-45.7), respectively. The HPV 16/18 genotyping test also performed as expected in women with ASC-US cytology who were positive for HR HPV..The Cervista HPV HR test can be clinically used for detecting HR HPV types in conjunction with cervical cytology for use in triage of women with ASC-US cytology during routine cervical cancer screening.
• Benning, B. R., & Lund, M. R. (2007). Patient knowledge about human papillomavirus and relationship to history of abnormal Papanicolaou test results.. Journal of lower genital tract disease, 11(1), 29-34. doi:10.1097/01.lgt.0000236969.27502.71
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  To assess patient knowledge about human papillomavirus (HPV) and determine if self-report of a previous abnormal Papanicolaou test result improves knowledge..A survey was designed and administered to patients at three obstetrics and gynecology clinics in Milwaukee, WI. The anonymous surveys assessed demographics, history of sexually transmitted infections or abnormal Papanicolaou test results, and knowledge about HPV and cervical cancer. The chi and Wilcoxon tests were used for statistical comparisons..Three hundred sixty-three surveys were collected, representing a diverse patient population. Forty-two percent of patients had heard of HPV. Women who reported a history of abnormal Papanicolaou test results were not more likely to have heard of HPV or to know that it causes cervical cancer than those who did not report abnormal Papanicolaou test results..There is no significant difference in knowledge about HPV between patients who reported a history of abnormal Papanicolaou tests and those who did not.
• Castle, P. E., Dockter, J., Giachetti, C., Garcia, F. A., Mccormick, M. K., Mitchell, A. L., Holladay, E. B., & Kolk, D. P. (2007). A cross-sectional study of a prototype carcinogenic human papillomavirus E6/E7 messenger RNA assay for detection of cervical precancer and cancer.. Clinical cancer research : an official journal of the American Association for Cancer Research, 13(9), 2599-605. doi:10.1158/1078-0432.ccr-06-2881
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  To evaluate carcinogenic human papillomavirus (HPV) mRNA for E6 and E7 mRNA detection on clinical specimens to identify women with cervical precancer and cancer..We evaluated a prototype assay that collectively detects oncogenes E6/E7 mRNA for 14 carcinogenic HPV genotypes on a sample of liquid cytology specimens (n=531), masked to clinical data and to the presence of HPV genotypes detected by PGMY09/11 L1 consensus primer PCR assay..We found an increasing likelihood of testing positive for carcinogenic HPV E6/E7 mRNA with increasing severity of cytology (P(Trend) < 0.0001) and histology (P(Trend) < 0.0001), with 94% of cervical intraepithelial neoplasia grade 3 (CIN3) histology cases (46 of 49) and all five cancer cases testing positive for carcinogenic HPV E6/E7 mRNA. Overall, fewer specimens tested positive for carcinogenic HPV E6/E7 mRNA than for carcinogenic HPV DNA (P
• Castle, P. E., Sadorra, M., Garcia, F. A., Cullen, A. P., Lorincz, A. T., Mitchell, A. L., Whitby, D., Chuke, R., & Kornegay, J. R. (2007). Mouthwash as a low-cost and safe specimen transport medium for human papillomavirus DNA testing of cervicovaginal specimens.. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology, 16(4), 840-3. doi:10.1158/1055-9965.epi-06-0909
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  The usefulness of mouthwash as a transport medium for cervical specimens for carcinogenic human papillomavirus (HPV) DNA testing has not been evaluated. Two cervical specimens were collected from each of 34 patients, with one placed in mouthwash (Scope, Proctor and Gamble, Inc.) and the other in a liquid cytology medium commonly used for HPV DNA testing in alternating order. Paired specimens were tested by a PCR assay for carcinogenic HPV and a PCR HPV genotyping assay for 37 HPV types at 0, 3, and 6 weeks after collection; the results of the HPV genotyping assay were categorized into HPV risk groups according to cancer risk (HPV-16 > HPV-18 > other carcinogenic HPV types > noncarcinogenic HPV types > negative). After 4 months of storage, specimens were tested using a second, non-PCR test for carcinogenic HPV. We observed a >or=94% total agreement and kappa values of >or=0.88 between media at each time point for PCR-detected carcinogenic HPV. We observed a >or=74% total agreement, >or=0.62 unweighted kappa, and >or=0.75 linearly weighted kappa between media at each time point for PCR-detected HPV cancer risk category. Finally, we observed an 88% total agreement and kappa of 0.77 between media for carcinogenic HPV detection using a second test after 4 months of storage. We suggest that mouthwash might be used as a low-cost, safe, nonflammable storage and transport medium for cervical specimens for HPV DNA testing in cervical cancer screening programs.
• Mitchell, A., Newton, J. M., Brite, K., Einspahr, J., Ellis, M., Davis, J., Nuno, T., Alberts, D. S., Garcia, F., Mitchell, A., Newton, J. M., Brite, K., Einspahr, J., Ellis, M., Davis, J., Nuno, T., Alberts, D. S., & Garcia, F. (2007). Cyclooxygenase 2 Expression in Cervical Intraepithelial Neoplasia and Vulvar Cancer. Journal of Lower Genital Tract Disease, 11(2), 80-85. doi:10.1097/01.lgt.0000236969.27502.71