Active clinical trials for "Uterine Cervical Neoplasms"

Aims of the Study: To assess feasibility and acceptability of introducing HPV testing of self-collected vaginal specimens (self-collection for HPV) of women age 30-49 years, followed by visual assessment of the cervix for treatment (VAT) and treatment of women testing HPV positive at a district hospital, surrounding clinics and communities in Botswana. Background and Rationale: High HIV prevalence correlates with high rates of precancerous and cancerous changes on the cervix, and Botswana has the third highest HIV prevalence rate (22.2%) in the world. In Botswana, cervical cancer is the leading cause of cancer and cancer-related deaths among women. While the Government of Botswana has made cervical cancer a public health priority, and has provided cytology-based screening (Pap smears) for the past 20 years and in recent years began also offering VIA coupled with immediate cryotherapy for eligible precancerous lesions in a screen-and-treat (S&T) approach, the program still encounters multiple challenges. These include delays in reporting/receiving cytology results, referral bottlenecks for specialist care, and ultimately far fewer women being screened and treated than set targets. In response, in 2012 Botswana's Ministry of Health and Wellness (MoHW) developed a National Cervical Cancer Prevention Programme (NCCPP) Comprehensive Prevention and Control Strategy that includes implementing a demonstration project to gauge acceptability and obtain lessons that will be used in planning the roll-out of this screening method. As a result, the MoHW is exploring human papillomavirus (HPV) testing as a primary screening method with the future service delivery in mind through HPV testing, specifically using self-collected samples, as a primary screening method. HPV testing is more sensitive and reliable for the detection of cervical precancer and cancer than Pap testing and VIA. This increased sensitivity translates into two important benefits: 1) earlier detection of significant precancerous lesions that if treated results in a ~50% reduction in the incidence of cervical cancer within 4-5 years compared to Pap testing and 50% reduction in related deaths within 8 years compared to Pap testing and VIA and 2) lower cancer risk for many years for those with a negative result, which permits screening at an extended interval of 5-10 years. The Xpert HPV test, which will be used in this study, has high sensitivity (100%) and relatively high specificity (81.5%) for CIN. HPV tests run on the GeneXpert® machine allow multiple tests (four in the model to be used in this study) to be run in an hour.

The purpose of this study is to develop, deliver and evaluate a provider intervention for mothers and their children to encourage receipt of the human papillomavirus (HPV) vaccine in the children and appropriate cervical cancer screening in the mothers.

This is a Phase III clinical trial of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The primary objective of this study is to demonstrate the efficacy of the vaccine against relevant outcomes in healthy women above 18 years old at enrolment. The secondary objectives are to evaluate the safety, immunogenicity and immuno-persistence of the vaccine. Meanwhile, this study tries to compare the difference of safety and immunogenicity among different lots. Approximately 6000 study subjects will be enrolled and randomly stratified into 2 groups and receive human papillomavirus (HPV) vaccine(three different lots) or commercialized hepatitis E vaccine(Hecolin) according to a 0-1-6 month schedule.

Cervical cancer remains a public health burden, particularly in developing countries such as sub-saharan Africa where the infrastructure for organized screening programs does not exist. As a result, other screening modalities (visual inspection with acetic acid) are the standard of care in such regions. It is now known, persistent infection with an oncogenic Human papillomavirus (HPV) type is a necessary precursor of cervical cancer and evidence is showing HPV testing is a potential, safe and effective alternative to cytology testing (The Pap smear). This study is evaluating the feasibility and acceptance of HPV self-collection vs. VIA in a cohort of women from Kisenyi, Uganda.

In this study, 400 Hispanic women will be recruited and randomized to one of three interventions: Control (no change); A low-intensity information program, consisting of a video approach educating women on the importance of cervical cancer screening; A higher intensity program consisting of the video plus a 'promotora' or lay-community health educator led intervention at the participant's home to encourage cervical cancer screening. The investigators will compare which intervention is most effective in encouraging Hispanic women to undergo cervical cancer screening (Pap test)

Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials. Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.

The aims of this study are: To determine feasibility of a school-based human papillomavirus (HPV) vaccination programme in Tanzania. To measure the uptake and acceptability of two different vaccination strategies in rural and urban schools. To examine the characteristics of accepters/refusers of vaccination and to identify reasons for acceptance, refusal or non-completion. To measure the cost of implementing a school-based HPV vaccination programme in Tanzania.

The purpose of this study is to determine whether a faith-placed lay health advisor intervention is effective in increasing use of Pap smears among middle-aged and older Appalachian women.

Parent study: A Coordinated Approach to Cancer and Health (CATCH), was designed to compare the efficacy of two intervention arms (described below) intended to increase breast, cervical, and colon cancer screening rates among patients served by community health centers. A central focus of CATCH is to evaluate sustainable strategies for maximizing cancer screening rates among populations facing significant cancer disparities. CATCH was conducted in partnership with the large health clinic in Massachusetts, which serves a largely Hispanic low income population. Focusing on the use of an Interactive Voice Response (IVR) telephone technology system, the study is examining the extent to which the IVR, when developed in a culturally sensitive and appropriate manner (focus groups will be conducted to inform the intervention), can improve breast, cervical and colon cancer screening rates compared to a control group. Furthermore, we plan to determine if pairing IVR with telephone calls from a prevention care coordinator (PCC) will result in higher screening rates (when compared to the IVR only group). We will determine the cost-effectiveness of IVR alone vs. IVR + PCC. Substudy: We conducted a substudy of the parent study, looking at a comparison of return rates of two colorectal cancer screening home test kits: Fecal Occult Bood Tests (gFOBTs) and Fecal Immunochemical Tests (FITs). As well we surveyed people who pick up one of these two types of tests to assess barriers and facilitators of returning the completed kit to the health center for assessment.

Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic lymph nodes staging has been successfully evaluated in women with early stage of vulvar cancer, cervical cancer, and endometrial cancer. Such a technique may offer several valuable advantages: a) it is readily applicable in clinical routine using a safe, inexpensive, and reproducible protocol; b) it may help to avoid the cost and the morbidity of unnecessary lymphadenectomy in the majority of cases with uninvolved sentinel lymph nodes; c) it has the potential to guide the surgeon to nodal regions that are not routinely dissected (i.e. pre-sacral, para-aortic nodes) and to identify micro-metastases that would have been ignored otherwise; d) it also offers the basis for sophisticated pathological analysis to detect sub-microscopic nodal metastases using either immunohistochemical or molecular biological techniques. So far, within the abdomen and the pelvis, the LM/SL technique alone is often blinded to the accurate localization of SLNs. The integration of computed tomography (CT) to single photon emission computed tomography (SPECT) devices in a single gantry (SPECT/CT) has allowed a significant gain in terms of diagnostic accuracy and anatomic precision; clinical examples include malignant melanoma, head and neck cancer, breast cancer, and bladder cancer. In a seminal series of 26 patients with cervical cancer (Zhang et al., 2006), SPECT/CT was recently found superior to conventional planar imaging for detection of SLN and accurate localization. A more recent study (Kushner al., 2007) has also highlighted the technical feasibility and the clinical added-value of a low-dose SPECT/CT in a series of 20 patients with early stage cervical cancer (IA2-IIA) who underwent LM/SL. In the light of the encouraging data from literature and our own preliminary clinical experience, we hypothesized that the use of LM/SL plus SPECT/CT may be of clinical interest in patients with gynecological cancers.