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A Pilot Study and Feasibility Evaluation of the Interrelationship Between Environmental and Genetic Factors in the Development of Squamous Cell Carcinoma (SCC) of the Head and Neck (SCCHN):

PURPOSE OF THE STUDY: Squamous cell carcinoma of the head and neck is a type of cancer that affects many people in Louisiana. This cancer has been linked to drinking and smoking. Louisiana has a higher rate of this cancer than the majority of the United States. Factors in addition to smoking and drinking may be involved and result in the higher head and neck cancer rate in our state. Other possible factors include diet, genes that make a protein that affects the body's use of the vitamins in the diet and a virus known as Human Papillomavirus, HPV. The purpose of this study is to collect dietary information as well as blood, saliva and tumor samples in order to see if these factors play a role in the development of this cancer.
DESCRIPTION OF THE STUDY: A total of 25 men and women with squamous cell cancer of the head and neck will be enrolled from the inpatient and outpatient services of the Medical Center of Louisiana, New Orleans. After informed consent, subjects who are enrolled will be asked a series of questions about their diet and smoking and drinking history. Subjects may be asked about sexual practices.Subjects undergoing either diagnostic biopsy or surgical removal of a tumor of the head and neck that is felt to be squamous cell carcinoma are eligible to enroll. After informed consent, the abnormal lesions and an area of similar surface type will be identified. These samples will: (1) be rubbed with a plastic (Dacron) swab, (2) be scraped with a brush (cytobrush) and (3) will have the growths entirely removed (excised) or a small piece removed (biopsied) depending on the size of the growth. The Head and Neck Surgeons will determine the best way to remove or biopsy tumor tissue. Levels of vitamins, changes in genes that may be related to dietary factors and the presence of HPV will be studied in the tissue samples. Blood will also be collected. Levels of vitamins, variations in a protein that affects the body's use of the vitamins, changes in genes that may be related to dietary factors and the presence of HPV will be studied in the blood samples. All subjects will also be asked to give 50-75 mls (5-8 tablespoons) of blood. The study will add approximately one hour to the visit. There are no planned follow up visits.

PURPOSE OF THE STUDY: You have been asked by your doctor to participate in a research study. The goal of this study is to determine possible improvements in the ability to detect infection with human papillomavirus (HPV) and herpes simplex virus type 2 (HSV2). HPV is the wart virus but can also cause cancer in the genital or anal tract. HSV2 causes genital lesions and ulcerations of the genital area and the skin surrounding the anus. This study is designed to compare patients with detected HSV or HPV to those without infection in respect to general health status and other infections like HIV. Swabs will be taken from different regions in the genital area and processed for detection of these viruses. These swabs are hoped to be more sensitive and more accurate. They are also less invasive than a blood draw, although some people might feel uncomfortable with swabs of the urethra and the anus. There is also concern whether patients with both HSV2 and HIV1 infection have a less favorable course than patients with either infection alone.
DESCRIPTION OF THE STUDY: A total of 50 HIV+ men will be recruited from the HIV Outpatient Program (HOP) at LSUHSC. After informed consent, a short questionnaire dealing with questions concerning sexual history and history of sexually transmitted diseases will be administered. Some of these question deal with intimate details and they might make you feel uncomfortable. Next, warts or lesions found in the genital areas in men and women will be sampled by wetting a dacron applicator with sterile normal saline, and swabbing the affected areas. Urine will also be collected. Finally, if blood is going to be drawn on this office visit, then 10 cc (2-3 teaspoons) of blood will be taken to detect HPV and HSV antibodies. For men, the clinician will (1) use 2 new wet swabs and sweep 360° around the tip of the penis (coronal sulcus and glans penis), (2) use a new swab to sample the entire skin surface of the shaft of the penis, (3) use a new swab to sample the scrotum, (4) the clinician will insert a smaller calcium alginate swab into the urethra and (5) an anal and perianal swab will be taken.

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A Double-Blind, Randomized, Controlled, Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women who are HSV-1 and -2 Seronegative:

PURPOSE: Herpes is a serious health problem and is one of the most common infections in humans. It is caused by a herpes simplex virus (HSV). Once infected, the herpes virus remains in your body (in the nervous system) for your entire life. Although many herpes infections show no symptoms at all, these infections can be a major source of stress and discomfort. The herpes virus produces small, irritating, (and sometimes painful), fluid-filled blisters on the skin and mucous membranes (for instances around the mouth, eyes and genital area). The symptoms are usually short-lived (2-3 weeks), but the virus may be reactivated (blister come back) at times of illness, physical or emotional stress, or by exposure to sunlight, certain foods or medications.
There are effective medicines against herpes which can decrease the symptoms associated with this disease; however, there is no cure for herpes simplex virus. Vaccines prevent disease by producing antibodies (substances made by your body to prevent infections) and cells that can fight the agent that causes the disease. This research is being done because currently, there is no effective vaccine for this disease. This investigational herpes vaccine has been tested already in about 7,400 subjects. Previous studies with this vaccine have shown that it protected nearly three-quarters of women against genital herpes disease. However, there is no evidence that the vaccine protected women who were infected with HSV-1 prior to vaccination. The vaccine is currently not licensed and is still considered as investigational.