View clinical trials related to Cervical Cancer.
Filter by:- Cervical cancer is caused by persistent infections with one of ~13 carcinogenic human papillomavirus (HPV) types and causes substantial morbidity and mortality worldwide. - Highly effective strategies exist, including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions. - The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzania's National Cervical Cancer Prevention (CECAP) program. - The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV+ Women Living with HIV (WLWH). - At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine. - The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region. Two clinics will be randomized to the test, treat and vaccinate strategy and two clinics will be randomized to test, treat and re-screen and then vaccinate strategy. - Currently, there is no Standard of Care (SOC) for vaccination of women who are at risk for HPV in the country. These two arms of the study will allow for treatment and observation to occur that would not be available otherwise.
GynRAN is an international, multicentre, transversal, diagnostic and non-interventional study carried out in gynecology-obstetrics/gynecological oncology departments that aims to identify a diagnostic signature for gynecological pathologies by analyzing of coding and non-coding RNA contained in patients saliva. The study population consists of patients with clinically symptomatic females with one or more of the gynecological pathologies (endometriosis, adenomyosis, ovarian cysts, fibroids, ovarian/cervical/uterine cancer) and asymptomatic females. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the local recommendations.
Objective: The main objective of this study is to verify the level of comfort for patients and the degree of cervical visibility for health providers using a novel smart speculum compared to the standard speculum. In addition, establish the feasibility of using this novel smart speculum device with telemedicine for cervical cancer screening in a low-resource setting using VIA compared to the standard of care. Study sites: The study will be carried out in six health facilities in the centre region of Cameroon. Study Period: The study is expected to take 11 months; 4 months for protocol development and approval, 4 months for the training and implementation phase with data collection, 3 months for data analysis, reporting writing and dissemination. Study design: The study will be a multicentre, randomised control single blind trial. Patient participation will be a single study visit. Eligible subjects, consenting to participate will act as their own controls, and will receive speculum examination and cervical cancer screening with both the novel speculum and a traditional speculum. The order of usage of the specula will be randomised, and the women will be blinded on knowing which speculum is being used at a particular time. Level of patient comfort will be evaluated using a visual analogue scale, percentage visualisation of the cervix will be determined following insertion of each of the specula, and results of cervical cancer screening following VIA screening method will be compared between the standard of care procedure to that using the novel smart speculum associated to telemedicine. Patient population: All women between the ages of 21 years and 49 years who come in for consultation. Enrolment size: 81 women will be enrolled in the study. Study procedure: A speculum examination will be done on the day of consultation. Level of patient comfort determined using a visual analogue scale and proportion of the cervix visualised would be recorded into questionnaires. Cervical cancer screening through VIA will be performed with results confirmed on site by the clinician using the standard speculum, while two other clinicians for each case will do a remote diagnosis after reviewing images captured through the novel speculum device and forwarded to them through telemedicine. The remote clinicians will be blinded on the diagnosis proposed by the clinician on site. Primary endpoints: The proportion of clinicians with easy visualisation of the cervix with the 2 specula, level of patient comfort with the novel smart speculum compared to the Standard of care speculum (traditional speculum), reliability of the speculum in carrying out cervical cancer screening using telemedicine. Ethical considerations: The protocol will be submitted for the approval of the National Human Health Research Committee. Written informed consent will be sought for all participants before enrolment into the study.
A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.
This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients.
The ETERNITY project is a retrospective analysis of outcomes of patients undergoing fertility-sparing treatment for cervcial cancer. The primary aim is to report outcomes of those patients. Other aims included: 1. Evaluation about the effectiveness of different treatment modalities; 2. Evaluation of outcomes according to different stages of disease; 3. Evaluation of the impactof neoadjuvant chemotherapy in patients undergoing conservative surgery
The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.
The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma. The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.
A Feasibility Trial of PVX7 vaccine in advanced cervical cancer patients who have completed primary definitive therapy.
ELEVATE is a six-year project, conducted by an international research alliance led by Ghent University, aiming to develop a new test and approach for cervical cancer screening in hard-to-reach populations. In this final stage of the project, a hospital-based validation study is deployed in Belgium and Ecuador to clinically validate the new ELEVATE screening test based on self-samples and endocervical samples. The simultaneous detection of HPV DNA and the proteomic markers allows for the detection of those cervical HPV infections associated with progression towards cervical cancer. At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear result will be recruited in the colposcopy waiting room. After registration and signing the informed consent form, each woman will be asked to fill out a short self-administered questionnaire for socio-demographic information. Each woman will provide a self-sample as well as an endocervical sample before the colposcopy examination. Both samples of all 200 women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE screening test, using 400 ELEVATE cartridges, as well as with standard tests. Besides analyzing all samples on the new ELEVATE screening test, the following standard tests will also be performed on all samples (at Ghent University - including the shipped samples of Ecuador): - AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test - ELISA protein detection: only available comparison test In order to generate HPV DNA results locally, that can be communicated to the participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results after shipment to Belgium), in Ecuador the following additional standard test will be performed on the100 endocervical samples (before shipment to Belgium): • HPV DNA Mole Bioscience test Concordance between the test results of the ELEVATE screening test and standard lab tests on both type of samples will be defined, for HPV DNA as well as protein detection. Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of the ELEVATE screening test will be defined, according to clinically relevant outcomes.