![]() ![]() Rapid test: A rapid test will be conducted on the cells from the tissue samples.This assay will allow for the detection of HPV types 6, 11, 16, and 18. Serology: The serum samples will be sent to the Merck research laboratories in the United States (Wayne Laboratories) and will be tested using the Luminex immunological assay. ![]() The serum samples will be stored at -20☌ and will be sent to the United States every four months for serological testing in the Merck laboratories. Blood samples will be sent to the laboratory for Applied Molecular Biology (LAMB/LBMA) located in Bamako, for centrifugation and serum aliquoting. Blood draws: Blood samples will be collected in order to measure antibodies against a panel of HPV types, including HPV 16 and 18.In order to collect the necessary data for this study, the following procedures will be used: not linked to the study), (c) agreed to have blood drawn, (d) was older than 18, and (e) had the capacity to give informed consent. The nurse will be in charge of briefly presenting the proposed study protocol and ensuring that the patient (a) had been positively diagnosed with cervical cancer (diagnoses are established from a clinical case and/or based on the patient's history), (b) voluntarily expressed a willingness to have a biopsy or other gynecological operations and have a doctor collect tissue samples during a "standard" medical appointment (i.e. During the study, each participant will sign a consent form and undergo an interview with a nurse. No biopsy will be done just for the sake of the study. Recruitment will be done during appointments either for a curative biopsy or for a more extensive surgical procedure. These patients will have been previously identified and diagnosed by clinical exam by an obstetrician-gynecologist at Gabriel Touré, and will have been identified as surgical candidates by a doctor. (i) We plan to identify and recruit a sample of 160 women diagnosed with cervical cancer within the department of gynecology of the Hospital Gabriel Touré in Bamako, Mali. Obtain information on preferred consenting, screening and notification practices. Use focus groups and house-by-house interviews as means of collecting data. (iii) Perform a survey evaluating the Knowledge Attitude and Practice (KAP) and Willingness To Participate (WTP) with regard to HPV and HPV vaccines in the proposed trials site (300 individuals will be asked to complete surveys with trained surveyors minimum of 100 adolescents and their 200 parents). (ii) Train local clinical staff to implement good clinical protocols and good clinical laboratory practices for cervical cancer screening, and establish HPV sub-typing methodology at the affiliated laboratory sites. Hôpital Touré is the referral center for cervical cancer patients from the entire city of Bamako (>1.8M inhabitants). (i) Evaluate, in a sample of 160 women diagnosed with cervical cancer recruited from the hospital Hôpital Touré, the prevalence of HPV subtypes associated with cervical cancer. Furthermore, few data are available on vaccine acceptability, health systems preparedness and vaccine cost-effectiveness and long-term impact in this region of the world. Prior to conducting a Phase IV trial, HPV subtyping should be studied. However, the impact of quadrivalent Gardasil vaccination in developing world settings, where HPV subtype prevalence may differ, is unknown. Human Papillomavirus (HPV) vaccination with the Gardasil vaccine has the potential to eradicate cervical cancer worldwide. Why Should I Register and Submit Results?. ![]()
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