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Showing 1-14 of 14 trials
NCT06874985
This study will be conducted as a parallel-arm, open-label, randomized controlled trial (RCT) to evaluate the effectiveness and impact of the Lived Experience Communication Campaign (LECC) on cancer screening participation rates \[oral, breast and cervical cancer\] compared to the usual standard awareness campaign across selected rural population in Villupuram district, Tamil Nadu.
NCT06919627
The aim of this retrospective, single-center, observational study is to improve the diagnosis and interpretation of cervical cancer by better detection of epithelial lesions in the case of a late HPV PCR amplification signal rendered negative by routine laboratory testing using GeneXpert® technology. The various evaluation criteria are : * Presence or absence of lesions on cytological control following a negative HPV test with a late amplification signal on cervico-uterine and anal smear samples from patients seen in consultation at Brest University Hospital from 01/01/2022 to 30/06/2024 (after conventional PCR and genotyping). * Comparison of the GeneXpert® technique with the results of another conventional pan-genotypic Papillomavirus PCR test.
NCT07038369
This is a Phase 1, open-label study to evaluate the safety and tolerability of ATV-1601 administered orally in adults with AKT1 E17K-mutant, advanced solid tumors and also in HR+/HER2- advanced and metastatic breast cancer, with or without fulvestrant.
NCT06349148
The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?
NCT07244965
This is a single-arm, phase II clinical trial evaluating the efficacy and safety of neoadjuvant Ivonescimab combined with paclitaxel and cisplatin (TP regimen), followed by concurrent chemoradiotherapy, in patients with high-risk, locally advanced cervical cancer (FIGO stage III-IVA). Eligible participants will receive two cycles of neoadjuvant Ivonescimab plus TP chemotherapy, followed by standard concurrent chemoradiotherapy. The primary endpoints include progression-free survival (PFS) and objective response rate (ORR) following neoadjuvant treatment. Secondary endpoints include overall survival (OS), disease control rate (DCR), safety, and quality of life (EORTC QLQ-C30). Exploratory analysis will focus on identifying predictive biomarkers for Ivonescimab efficacy.
NCT07213427
Background and Rationale: Locally advanced cervical cancer remains a major public health concern worldwide and in France. Standard-of-care management involves concurrent chemoradiotherapy followed by brachytherapy, which is critical for local tumour control and survival. Conventional high-dose-rate (HDR) brachytherapy protocols often require multiple implantations under anaesthesia, entailing increased logistical demands, operating room use, and patient discomfort. The UNICURE-HD study investigates a simplified brachytherapy approach - a single intraoperative implantation delivering all planned fractions - combined with image guidance (MRI and/or CT) and 3D dosimetry, in order to assess whether it can maintain oncological outcomes while reducing treatment complexity and resource consumption. Objectives: Primary objective: To evaluate local control at 3 and 5 years after completion of chemoradiotherapy and image-guided HDR uterovaginal brachytherapy with single implantation. Secondary objectives: To assess pelvic nodal control, para-aortic nodal control, distant control, progression-free survival, overall survival, and acute/late severe toxicities (CTCAE v5.0 ≥ grade 3). Prognostic factors will be analysed, and exploratory predictive models will be developed. Study Design: This is a retrospective, observational, multicentre study involving six French cancer centres (Pitié-Salpêtrière, Saint-Louis, Tenon, Institut de Cancérologie de Lorraine, Centre Oscar Lambret, CHU de La Réunion). Eligible patients are women ≥18 years, diagnosed with FIGO 2018 stage IB3-IV cervical cancer, treated between January 2014 and June 2024 with concurrent chemoradiotherapy followed by image-guided HDR uterovaginal brachytherapy using a single implantation. Methods: Data will be extracted from medical records (electronic or paper), pseudonymised locally, and entered into a secure AP-HP-hosted database compliant with GDPR and the MR004 framework. Variables collected include demographics, tumour characteristics, EBRT details, brachytherapy technique (endocavitary vs hybrid/interstitial), dosimetric parameters (EQD2 for HR-CTV, IR-CTV, OARs), and outcomes. Imaging protocols, applicator types, and treatment times will also be recorded. Statistical analysis will use descriptive statistics, Kaplan-Meier survival estimation, log-rank tests, and multivariable Cox regression. Predictive models (LASSO, random forests) will be explored. Analyses will be conducted in R software. Sample Size: Approximately 400 patients are expected, representing all eligible cases treated over the 10-year period in the participating centres. Ethics and Regulatory Compliance: The study follows GDPR and French data protection regulations (MR004). Ethics opinion has been requested from the Sorbonne Université Ethics Committee. Each centre will retain the correspondence table linking identifiers to pseudonyms locally; no directly identifying data will be shared. Potential Impact: If the single-implantation HDR brachytherapy strategy achieves equivalent tumour control and toxicity profiles compared to multi-implant protocols, it could streamline cervical cancer management, reduce anaesthetic risk, improve patient comfort, and optimise resource use in high-volume oncology departments. This could have significant implications for accessibility and cost-effectiveness of cervical cancer care, particularly in settings with limited resources.
NCT06669533
This is a double-blind randomized controlled trial of 420 non-pregnant women undergoing cancer screening by visual inspection with acetic acid (VIA) who have Type 3 transformation zone (TZ) and randomized to receive either Misoprostol or placebo.
NCT07003620
This is a prospective, single-arm, Phase II clinical trial designed to evaluate the efficacy and safety of paclitaxel and carboplatin combined with PD-1/PD-L1 immune checkpoint inhibitors in the treatment of locally advanced cervical cancer. Using single-cell RNA sequencing (scRNA-seq), the study aims to investigate the molecular mechanisms underlying differential treatment responses and optimize personalized therapeutic strategies. Eligibility Criteria: Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \>4 cm will be enrolled. All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, an ECOG performance status of 0-1, and no prior treatment. Outcome Measures: * Primary endpoint: Objective response rate (ORR), assessing tumor regression. * Secondary endpoints:Overall survival (OS), progression-free survival (PFS), and incidence of treatment-related adverse events (graded by CTCAE criteria). * Exploratory endpoint:\*\* Impact of treatment on the tumor microenvironment and gene expression profiles. Study Intervention: All patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis. Sample Size: The study plans to enroll at least 34 eligible patients. Based on treatment response, patients will be categorized into high-response and low-response groups, with a minimum of 5 cases per group selected for scRNA-seq to ensure robust molecular mechanism analysis. The sample size calculation assumes a historical ORR of 65% and a target ORR of 85%.
NCT07022470
This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.
NCT06929234
Women's knowledge, attitudes and behaviors about cancer are very important in the prevention of cervical cancer. In addition to medical interventions, psychosocial support and education programs are of great importance in the fight against cancer. Peer support helps individuals going through the same disease process to exchange information and emotional support by sharing their experiences with each other. In addition, the information obtained through peer support provides more permanent learning in individuals due to the transfer of information based on similar experiences and the creation of more trust and empathy compared to traditional education methods. Peer-supported education programs for women diagnosed with cervical cancer not only provide theoretical knowledge but also support the applicability of this knowledge in daily life. The trainings address topics such as risk factors of cervical cancer, the importance of HPV vaccination, the necessity of regular screening tests and healthy lifestyle behaviors, including attitudes towards cervical cancer prevention and cancer-related information. It is very important that this information is not limited to individual learning and that it is discussed within the group and supported by experiences through peer support, in order to increase the level of knowledge.
NCT06878222
Currently, the survival rate of locally advanced cervical cancer is low, posing a significant challenge in the treatment of cervical cancer. Radical chemoradiotherapy is considered the standard treatment for patients with locally advanced cervical cancer. However, 23.3% to 34.4% of patients still experience recurrence or subsequent metastasis. Radical surgery following neoadjuvant chemotherapy is an alternative to concurrent chemoradiotherapy, but it also has limitations: for approximately 9.8% to 30.6% of patients who do not respond to neoadjuvant chemotherapy, effective local treatment may be delayed. Additionally, more than 30% of patients still require adjuvant radiotherapy or chemoradiotherapy after surgery, significantly increasing the risk of complications. Therefore, there is an urgent need to explore alternative or improved treatment methods for neoadjuvant chemotherapy in locally advanced cervical cancer. An increasing number of women are being diagnosed with cervical cancer during their childbearing years, many of whom have a desire to preserve their fertility. For selected patients with stage IB2 cervical cancer, options include abdominal radical trachelectomy or radical trachelectomy following neoadjuvant chemotherapy. However, compared to conservative surgeries such as conization or partial cervical resection, radical trachelectomy is associated with less favorable fertility rates and pregnancy outcomes, with significantly higher rates of infertility, miscarriage, and preterm birth. For patients with stage IB3 or IIA1-IIA2 cervical cancer, the current standard surgical approach is radical hysterectomy, which does not preserve fertility. Current research suggests that neoadjuvant chemotherapy can shrink tumor size, decrease lymph node and distant metastases, and reduce the need for postoperative adjuvant radiotherapy. This offers hope for young cervical cancer patients who wish to preserve fertility, as it may reduce tumor size, thereby allowing for less extensive fertility-sparing surgery, improving pregnancy outcomes, or even making fertility-sparing surgery a viable option. In recent years, immunotherapy has gradually become a research hotspot in cancer treatment. Anti-PD-1/PD-L1 monoclonal antibodies, as a type of immunotherapy drug, have demonstrated promising anti-tumor efficacy and low side effects in clinical trials. Iparomlimab and Tuvonralimab is a novel therapeutic biological product targeting both PD-1 and CTLA-4. It is composed of two engineered monoclonal antibodies (anti-PD-1 and anti-CTLA-4) expressed in a fixed ratio and has shown significant efficacy in cervical cancer patients. Therefore, given the urgent need to improve neoadjuvant therapy for locally advanced cervical cancer and fertility-preserving neoadjuvant therapy for early-stage cervical cancer patients, this study is being conducted to explore and evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with paclitaxel and cisplatin as neoadjuvant therapy for cervical cancer. Additionally, the study aims to investigate the relationship between tumor-related biomarkers and the risk of recurrence.
NCT06823817
Colposcopy has become an important link and tool in the prevention and treatment of cervical cancer. The quality and pathological assessment of colposcopy is a key point in follow-up and treatment.The main purpose of this study was to analyze the correlation between colposcopy indications and pathological findings.
NCT06700941
The goal of this observational study is to assess the impact of HPV vaccination on cervical lesions and genital warts in Colombian birth cohorts. The study examines the trends in healthcare services usage related to these conditions, particularly among vaccinated and unvaccinated populations. The main questions it aims to answer are: Have health services usage rates for preneoplastic cervical lesions and genital warts decreased among cohorts of girls eligible for HPV vaccination after the vaccine's introduction? Have there been reductions in health services usage for genital warts among male cohorts of the same birth years as vaccinated girls? Researchers will compare health services usage trends between vaccinated and unvaccinated populations, as well as geographical areas with differing levels of HPV vaccination coverage, to evaluate the impact of the HPV vaccination program. Participants will not be directly involved, as this is a retrospective analysis of existing healthcare records from various national databases, assessing the frequency of healthcare services related to preneoplastic lesions and genital warts, as well as vaccination coverage at national, departmental, and municipal levels.
NCT00943722
This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus \[HPV\] L1 virus-like particle \[VLP\] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503. The primary hypotheses are as follows: 1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated. 2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3. 3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3. 4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.