Clinical Research – Gynecologic Oncology
FACTORS AFFECTING HUMAN PAPILLOMA VIRUS (HPV) VACCINATION IN POOR AND UNDERSERVED GIRLS
This study will determine the HPV vaccination rate in a racially diverse cohort of poor and underserved girls ages 11-18. We will also examine reasons why parents decide to vaccinate or decide not to vaccinate their daughters. We will review medical records to determine how many girls are vaccinated against HPV as compared with tetanus (TdaP). We will calculate the percentage of girls who are vaccinated in the whole population, and then we will compare individual racial groups. Parents will be interviewed to determine what influences their decisions to vaccinate or not to vaccinate their daughters. Specifically, we will ask about HPV-related knowledge, beliefs about vaccination causing promiscuity, feelings about other vaccines, and trust in their doctors. Using the data collected from this research, we will design a culturally-appropriate educational program to maximize vaccination rates in disadvantaged racial groups.
WHAT PARENTAL FACTORS INFLUENCE ACCEPTANCE OF THE HPV VACCINE?
Cervical cancer is caused by certain strains of the Human Papilloma Virus (HPV), which is a sexually transmitted virus. Gardasil, a vaccine effective against the strains of HPV that cause 70% of cervical cancers is now FDA approved and recommended for young women aged 11-26 by the Advisory Committee on Immunization Practices. Controversy exists about this vaccine because some parents fear that vaccinating young girls against a sexually transmitted disease may encourage promiscuity.
African-American, Haitian and Latina women have higher rates of cervical cancer than Caucasian women in the US. Universal vaccination has reduced racial disparities in the rates of other vaccine-preventable diseases, and the HPV vaccine holds great promise for reducing the current racial disparities in cervical cancer rates. However, African-Americans and Latinas are also less likely to use preventive services, and therefore may not be as likely to receive the HPV vaccine as Caucasians.
This study will determine factors affecting parental acceptance of HPV vaccination for their daughters. Parents will be interviewed to understand their views on vaccines in general, their knowledge of HPV, and their health literacy. The purpose of the study is to identify knowledge deficits or health beliefs that are associated with refusal of vaccination. Using this knowledge, we will be able to create culturally appropriate health education programs to encourage vaccination.
DEMOGRAPHIC CORRELATES OF HUMAN PAPILLOMA VIRUS (HPV) VACCINE ACCEPTANCE IN HONDURAN WOMEN
This study will explore knowledge related to cervical cancer and the HPV vaccine in a cohort of Honduran women. Demographic factors, prior Pap smear and sexually transmitted disease histories, and cervical cancer knowledge will be abstracted from medical records and correlated with women's reported likelihood of accepting HPV vaccination if it were available for themselves and their daughters.
COST-EFFECTIVENESS OF VISUAL INSPECTION WITH ACETIC ACID (VIA) COMPARED TO THAT OF PAP SMEARS FOR CERVICAL CANCER SCREENING IN HONDURAS
This study will compare the cost-effectiveness of Pap smears to that of visual inspection with acetic acid (VIA) for cervical cancer screening in Honduras. Cost effectiveness and decision analysis will be performed. The primary outcome variable will be 10-year cancer prevalence. Three hypothetical populations of 35-year-old women will be compared: never-screened women, women screened with VIA, and women screened with Pap smears. Primary data from our cervical cancer screening program in Honduras will be used to determine screening characteristics of Pap smear and VIA, loss-to-follow-up, prevalence of precancerous lesions, and cost of screening and treatment. Published data will be used to model the natural history of cervical dysplasia with and without treatment.
Study Conducted in Collaboration with Aids Malignancy Program
AMC - RATES OF HPV VACCINATION IN MINORITY POPULATIONS
Cervical cancer is caused by certain strains of the Human Papilloma Virus (HPV), which is a sexually transmitted virus. Gardasil, a vaccine effective against the strains of HPV that cause 70% of cervical cancers is now FDA approved and recommended for young women aged 11-26 by the Advisory Committee on Immunization Practices. Controversy exists about this vaccine because some parents fear that vaccinating young girls against a sexually transmitted disease may encourage promiscuity. African-American and Latina women have higher rates of cervical cancer than Caucasian women in the United States. Universal vaccination has reduced racial disparities in the rates of other vaccine-preventable diseases, and the HPV vaccine holds great promise for reducing the current racial disparities in cervical cancer rates. However, African-Americans and Latinas are also less likely to use preventive services, and therefore may not be as likely to receive the HPV vaccine as Caucasians.
This study will determine the HPV vaccination rate in a racially diverse cohort of poor and underserved girls ages 11- 18. We will review medical records to determine how many girls are vaccinated against HPV as compared with tetanus (TdaP). We will calculate the percentage of girls who are vaccinated in the whole population, and then we will compare individual racial groups. Using medical record review, we will determine reasons why parents have declined vaccination as recorded by their children's pediatrician in the visit notes. Using the data collected from this research, we will be able to target groups who decline vaccination and may therefore benefit from intensified outreach.
AMC - A SINGLE-ARM, OPEN-LABEL PILOT TRIAL OF THE SAFETY AND IMMUNOGENICITY OF A QUADRIVALENT HUMAN PAPILLOMAVIRUS VACCINE IN HIV-1-INFECTED MEN
This is an open-label, phase 2, single arm pilot study that aims to assess the safety and tolerability of the quadrivalent HPV recombinant vaccine in HIV-infected men as well as the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in men who are antibody negative at baseline. All eligible participants will be vaccinated with the Quadrivalent Human Papillomavirus Recombinant vaccine (0.5 mL Gardasil®) by intramuscular injection at Day 0, Weeks 8 and 24. This study will enroll 110 subjects. A maximum of 20 subjects will be enrolled who are HPV DNA PCR-positive for HPV 16 in the anal canal, and 20 subjects who are HPV DNA PCR-positive for HPV 18. At least 25 subjects will be enrolled who are off antiretroviral therapy. The duration for enrolled subjects will be 72 weeks. The duration of the whole study will be 3 years.
PHASE IIA TRIAL OF 1% TOPICAL CIDOFOVIR FOR TREATMENT OF HIGH-GRADE PERIANAL SQUAMOUS INTRAEPITHELIAL LESIONS IN HIV-INFECTED MEN AND WOMEN
This is an open label, Phase IIA clinical intervention study. We plan to enroll up to 33 HIV-infected subjects with biopsy proven high-grade perianal dysplasia (perianal HSIL). Subjects will be treated with 1% topical cidofovir using a standard treatment protocol. Topical cidofovir will be self-applied once daily for 5 consecutive days and will have no treatment for the remaining 9 days (a treatment cycle). Subjects will be evaluated by a study clinician at the completion of each treatment cycle. Treatment cycles will continue for six treatment cycles. Exit evaluation will include a biopsy within 6 weeks of completing the final treatment cycle. Additional Sample Donation will be requseted from the subjects. The study subjects will be asked if they agree to donate 20 mL (4 Teaspoons) extra blood to be stored for future use. Also, they will be asked to approve that the leftover tissue sample be stored for future use in NCI Bank for tissues and biological fluids for HIV positive and HIV negative individuals. No other samples will be requested.
Studies Conducted in Collaboration with
Massachusetts Institute of Technology:
Imaging Studies - Cervical
OPTICAL DETECTION OF CERVICAL HIGH GRADE SQUAMOUS INTRAEPITHELIAL LESION
The purpose of this study is to test the clinical suitability of a red light probe (RLP) for identifying high-grade squamous intraepithelial lesions (HSIL) in cervical tissue. We will begin by conducting a pilot study on ten patients to test the clinical suitability of RLP used during a colposcopic examination. For each colposcopy patient, the probe will be placed in contact with the cervix and measurements are acquired. After all measurements are complete, the probe will be disinfected in time for use on the next patient. The study has two aims. 1) Determine if RLP is able to obtain reproducible measurements from the same tissue site. 2) Determine if RLP obtains physiologically relevant measures of tissue reflectivity across multiple patients. The study will conclude when both aims are met. This may require instrument and procedure modifications.
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SPECTROSCOPIC IMAGING AND DIAGNOSIS OF CERVICAL NEOPLASIA
Women with an abnormal cervical pap test are referred for colposcopic examination with possible biopsy to diagnose precancerous changes in the cervix. This study aims to develop an optical device, using spectroscopy techniques, for making these diagnoses.
Spectroscopic techniques are based on the measurement of the pattern and intensity of the reflected or fluorescent light to extract the chemical and structural composition of tissue. The use of spectroscopic techniques as a tool for diagnosis of disease relies on the hypothesis that the chemical composition and/or architecture of normal tissue is different from that of diseased tissue. The subjects will only be contacted initially, at the time of their visit in the colposcopy clinic. If the subject is required for their standard of care to return to the colposcopy clinic for follow-up visits, and she meets all inclusion and exclusion criteria, she will be approached again to participate in research study.
Imaging Studies – Anal
SPECTROSCOPIC IMAGING AND DIAGNOSIS OF ANAL NEOPLASIA
This study aims to develop an optically based technique for the diagnosis of neoplastic changes in the anus. Based on the success of the cervical and oral spectroscopic studies we believe that optically based technique would be beneficial for the diagnosis of anal dysplasia. Anal and cervical dysplasia and cancers have many similarities: They are both strongly associated with infection with the human papillomavirus, arise in the transformation zone and have similar histology. The spectroscopic device used will be the same device used in the cervical neoplasia project. The subjects will be contacted at the time of their High Resolution Anoscopy clinic visit and will be asked if they would like to participate in this research study.
FREQUENCY OF ANAL CYTOLOGIC ABNORMALITIES IN HIV INFECTED WOMEN AND THEIR HISTOLOGIC CORRELATES
The objective of this study is to estimate the prevalence and incidence of anal cytological and histological abnormalities in HIV infected women seen at Boston Medical Center. This study consists of an initial visit where HIV infected women presenting for gynecologic care will be approached. Routine cervical Pap test and human papilloma virus (HPV) hybrid capture assay for high-risk associated HPV types are performed on all cervical and anal cytology specimens. Patients with either abnormal anal cytology or infection with HPV in the anal canal will be referred for further evaluation with High Resolution Anoscopy. Patients with a normal anal cytology and negative anal HPV results will be recommended to return to clinic in 6 months for repeat cervical and anal pap tests.