View clinical trials related to Cervical Neoplasia.
Filter by:Longitudinal study in Burundi to evaluate the effectiveness, the acceptability and safety of thermal ablation in the treatment of cervical neoplasia.
When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low. Thus, a technology that improves the accuracy of the colposcopic exam is needed. This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.
The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).
Background: - National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B. Objectives: - To offer participants in the Costa Rica Vaccine Trial the vaccine that they did not receive during the masked portion of the trial (HPV vaccine or hepatitis A vaccine) and hepatitis B vaccination. - To collect information about exposure to known and suspected risk factors for HPV infection and cervical cancer from women who are receiving vaccination against HPV at crossover. Eligibility: - Women who participated in National Cancer Institute Protocol 04-C-N191. Design: - All participants will be offered vaccination against hepatitis B. - Women who received the hepatitis A vaccine during the trial will be offered vaccination against HPV. - Women who received the HPV vaccine during the trial will be offered vaccination against hepatitis A. - Appropriate vaccinations (including a combined hepatitis A and hepatitis B vaccine) will be available to reduce the number of injections that participants will be asked to receive. - All vaccines will be given according to the manufacturer's specifications for appropriate length of time between vaccine doses.
The overall objective of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix. The specific aims of the study are: - To compare information obtained from fluorescence and reflectance spectroscopic measurements of the cervix with standard methods for detecting cervical pre-cancers. - To validate previously developed algorithms for discriminating between normal and pre-cancerous tissue based on spectroscopic measurements. - To evaluate the safety of spectroscopic measurement of cervical tissue.
The aim of this study is to see whether a new self-sampling device, the Delphi Screener (Delphi Devices, Scherpenzeel, Netherlands), can be used for cervical cancer screening. The results using the new device will be compared to results using the current gold standard. The gold standard is clinician-collected endo-cervical and ecto-cervical specimens (often referred to as a 'Pap smear'). Additionally, women will be asked about the acceptability of using the device and how easy it is to understand the user instructions. The Delphi Screener is a sterile, plastic, syringe-like device containing buffered saline which allows a woman to collect her own vaginal lavage (to 'self-squirt'). The hypothesis is that the device may work well for cervical cytology and will be acceptable to the women in the study.
The overall objective of this study is to identify potential improvements for a noninvasive method of diagnosing dysplasia and neoplasia in the cervix using Multi-spectral Digital Colposcopy (MDC), a device that uses fluorescence and reflectance spectroscopy to compare images to histopathologic mapping of the cervical epithelium. Primary Objective: -To measure Multi-spectral Digital Colposcopy images in vivo of the cervix both before and after acetic acid in a screening population.This is a second generation research device with low significant risk for which we are studying MDC. Secondary Objectives: 1. To evaluate the effect of the fading of acetic acid in the image contrast obtained over time to see if this fading can predict the presence of any neoplasia. 2. To evaluate mapping the cervix so that software can reconstruct the cervical epithelial map as evaluated by a Papanicolaou Smear to compare to routine colposcopic images as well as those from the Multi-spectral Digital Colposcopy (MDC).
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Background: - In most women, HPV infection does not cause symptoms and the infection goes away on its own. In a small percentage of women, the HPV infection does not go away and sometimes can result in cervical precancer or cancer. - There are several different types of HPV. A better understanding of which types are related to cervical precancer and cancer may help guide doctors in clinical management of women who test positive for HPV and better understand why some women develop disease while others do not. Objectives: - To determine whether certain types of HPV are more risky than others and if so, whether they warrant separate detection in screening for cervical precancer and cancer. - To determine if lasting infection by different HPV types carry different risk of cervical precancer and cancer. - To determine what viral and genetic factors influence the development of cervical precancer and cancer. - To evaluate new HPV tests and new biomarkers of cervical cancer risk. Eligibility: -Women 30 years of age and older who are in the cervical cancer screening program at the Kaiser Permanente health plan in Northern California. Women who tested positive for HPV and a random sample of women who tested negative for the virus are included. Design: -Data about participants genetic background and the type of carcinogenic HPV with which they are infected are analyzed.
A population-based study was initiated in Costa Rica in June 1993 to investigate the natural history of human papillomaviruses (HPV) and cervical neoplasia. Over a period of 18 months, ending in December 1994, 10,080 women were recruited into our study, after informed consent was obtained. At the initial recruitment visit, all women were administered a brief risk factor questionnaire, had 15ml of blood collected and, if sexually active, were given a pelvic examination. At the time of the pelvic examination, a Pap smear was collected, as were additional cervical cells which were then used for additional monolayer smears (ThinPrep) and for human papillomavirus and other testing. Pictures of the cervix, known as cervigrams, were also taken as a third screening test. Based on these screening tests, women were referred to colposcopy, at which time a more detailed risk factor questionnaire was administered, additional cervical cells and blood (15ml) were collected, and histological specimens were obtained, if indicated by the colposcopy. Women diagnosed with a high-grade cervical lesion (HSIL) or cervical cancer were treated by Social Security Administration clinicians using standard local protocols. Women without evidence of HSIL or cancer at enrollment comprise the group of subjects who have been followed as part of our longitudinal study. Three distinct groups of women of approximately equal size (about 3,000 women each) exist within our longitudinal cohort. The first group consists of women who at enrollment had evidence of low-grade cervical lesions (LSIL) or equivocal lesions and a sample of the remaining cohort members. This group is being followed actively at 6-12 month intervals through their seventh anniversary in the cohort. The second group consists of women who were cytologically normal at enrollment but randomly selected for active follow-up. This second group will be seen once after enrollment, at their fifth anniversary in the cohort. Women in this group with evidence of LSIL at the fifth anniversary visit will be added to the first group described above and followed at 6-month intervals. The final group consists of the remaining women in our cohort (all cytologically normal at enrollment). These women are being followed passively via linkage to the cytology and tumor registries in Cost Rica. Clinical visits conducted during follow-up consist of a brief personal interview that collects information on exposures since enrollment, the collection of 15ml blood, and a pelvic examination. Pap smear is prepared during the pelvic examination, and additional cervical specimens are collected and used to prepare a monolayer smear (ThinPrep) and for human papillomavirus and other testing. Similar to the enrollment visit, cervigrams are also collected from each participant at the time of their follow-up visits. During follow-up, women with any evidence of progression to HSIL or cancer (by Pap smear, ThinPrep, cervicography, or by visual inspection) are referred to colposcopy, censored from the study, and treated by Social Security Administration clinicians using standard local protocols.