View clinical trials related to Cervical Intraepithelial Neoplasia.
Filter by:The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined according to the colposcopic evaluation of the patient. In case colposcopy findings are satisfactory (visible squamocolumnar junction), both ablative and excisional methods are adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the cold knife conization surgical technique to reduce blood loss. Some authors recommend that these branches should be ligated, but it remains unclear whether these sutures are actually effective in reducing bleeding.This study compared blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures.
The main objective of the study is to identify whether or not being informed infrequently results about screening is: 1) At least as safe and accurate as frequently obtaining all information from the present combination of opportunistic/organized cervical screening by comparing regimen results of three screening visits at the ages of 22, 25 and 30 years (Arm A1) vs. results of one screening visit at the age of 30 years (Arm A2) in Human papillomavirus (HPV) vaccinated young women.
This trial studies the prevalence of anal dysplasia and anal cancer in patients with cervical, vaginal, and vulvar dysplasia and cancer. Studying samples collected from patients in the laboratory may help doctors learn more about the human papillomavirus and how often anal cancer occurs in patients with cervix, vagina, or vulvar cancer.
The purpose of this study is to determine the optimal dose of GX-188E for the Phase 3 and access the efficacy and safety of GX-188E according the protocol in patients with Cervical Intraepithelial Neoplasia 3 (CIN3).
OBJECTIVE: The standard of care for high grade cervical intraepithelial neoplasia grade 2 to 3 (CIN 2-3) has been the excision of the cervical transformation zone by way of a loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC). However, it has been recognized that these procedures can increase the risks for pre-term labor in women who still desire to conceive. Recent studies have shown that medical treatment with Imiquimod, a topical immune response modulator, has significant effects on histological regression of CIN 2-3 when compared with placebo. The investigators propose that treatment with Imiquimod may be preferable offering similar outcomes on histological regression when compared with excision or ablation while potentially avoiding or reducing the number of surgical procedure that places them at risk for future pregnancies.
There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will
This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.
Cervical cancer is a leading cause of mortality among women in developing countries. A key factor has been the failure to achieve good coverage. The development in the last years of HPV-DNA based tests has changed the scenario, because it combines a high performance to detect disease with a reduction of screening frequency. Through self-testing, HPV testing has the potential of reducing social and health service barriers faced by women to access screening. This study is carried out in Jujuy, one of the Argentinian provinces with highest cervical cancer mortality rates and where HPV testing has been introduced as a primary screening test for all women attending public health sector. The study was conducted between July 2012-December 2013, and supported by the Argentinean National Cancer Institute. The protocol was approved by the institutional review committees of the Ministry of Health of Jujuy. This trial is a randomized by population clusters study that aims to assess the effectiveness of self-testing to increase coverage. The aims of this study are: a) to assess the self-test effectiveness to increase the participation of women in screening programs, b) to assess the self-test acceptability by women, c) to assess HPV self-test effectiveness measurement for the detection of CIN2+ lesions against cytology in primary screening. An overall number of 200 community health workers (CHWs) from the Primary Health Care System (PHCS) of Jujuy will be randomized into two groups that will be named Self-test Group (ST) and Conventional Sample Group (CS): 1. ST Group: CHWs will invite eligible women of their area to choose between doing a self-test or having a conventional sample taken by a health professional of the closest health care center. 2. CS Group: CHWs will invite eligible women in their area to have a conventional sample taken by a health care professional of the nearest health care center. In order to measure the self-test relative sensitivity against cytology to detect CIN2+ in primary screening, all the women in the Self-test Group who have decided to do the self-test and all the women of 30 years of age and older that were screened with cytology by the provincial program for the prevention of cervical cancer in 2011 will be considered. A database built specifically for the study will be used; it will hold the list of eligible women to participate in the study. The records of women of 30 years of age and older residing in the areas included in the study will be imported from the PHCS databases. In addition, the data surveyed by the study will be uploaded: randomization Group, presence of the woman at home during the CHW's visit, agreement to participate in the study, realization of self-test (in the corresponding group), and if appropriate, reasons for not doing the self-test. Lastly, the HPV Test realization will be uploaded importing the data on SITAM, (link of data done as from the identity card number). Data Analysis Self-test acceptability: Acceptability is defined as the number of women accepting the self-test against the number of women offered the option between the self-test and the conventional sample (proportion of women accepting the self-test). The acceptability in this population will be estimated as the average of acceptabilities calculated by CHW, as to control the impact of the CHWs on acceptability and reach an appropriate variance estimate. Besides, the variability introduced by the CHWs on acceptability will be studied and the results obtained by male and female CHWs will be compared, as well as those obtained by the CHWs in rural and urban areas. Self-test effectiveness to enhance participation of women in screening and diagnosis: There will be a comparison of the percentage of women that did the HPV test in the Self-test group and the Conventional sample group. Three different coverage indicators will be considered for every CHW. These will be defined as the number of women screened within the field work regarding: 1. The number of women reached by the CHW who accepted participating in the study. 2. The number of eligible women for that CHW (regardless of whether the CHW was able to contact them or not). The effect of the strategy (offering the self-test option against promotion of the conventional sample) will be estimated for each one of the coverage measures using a means difference test or a non-parametric test for independent samples. CIN 2+ detection rate: The effectiveness of the HPV Self-test against screening cytology to detect CIN2+ will be estimated as the detection rates difference and as the detection rates ratio. In addition, there will be a comparison of the CIN2+ detection rate in the group of women who did the self-test against the total number of women in the province of Jujuy that were tested for HPV (conventional sample strategy + triage Pap test) until December 2012.
Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting.
Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each based on a modified "3 + 3" dose-escalation study design. The study will be initiated with Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose escalation will be based on safety evaluation for determination of potential dose-limiting toxicity (DLT).