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Cervix Cancer clinical trials

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NCT ID: NCT06452004 Active, not recruiting - HPV Infection Clinical Trials

Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)

AI-DSS
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

The research project is a component of another research project that applies the protocol of the World Health Organization for screening of cervical cancer, with testing of high-risk Human Papilloma Virus (hrHPV) as first screening. In the screen, triage and treat approach women who tested positive for hrHPV are undergoing Visual Inspection of the cervix with Acetic Acid (VIA). This procedure is applied in Uganda, India and Bangladesh. However the quality of VIA by lower-trained staff is variable because Low and Middle Income Countries face limited numbers of qualified health care professionals. Artificial intelligence (AI) might be a solution to improve consistency of VIA assessment. This research validates an AI decision support system (AI-DSS) under field conditions.

NCT ID: NCT06416748 Not yet recruiting - Cervical Cancer Clinical Trials

Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

LASH
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.

NCT ID: NCT06383507 Not yet recruiting - Ovarian Cancer Clinical Trials

A Clinical Study of Anti-CD70 UCAR-T in Relapsed or Refractory Solid Tumors

Start date: April 22, 2024
Phase: Phase 1
Study type: Interventional

This is a single-center, single-arm ,open-label ,dose escalation and dose extension study. In this study we plan to evaluate the safety and efficacy of CD70-targeting UCAR-T cells in the treatment of CD70-positive refractory or relapsed solid tumors, and obtain recommended doses and infusion patterns.

NCT ID: NCT06371118 Recruiting - Cervix Cancer Clinical Trials

HPV Self-sampling for Women Who do Not Attend Cervical Cancer Screening Programme

HERSELF
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

This study aims to test the effectiveness and cost-effectiveness of two different strategies of home-delivered HPV self-sampling, in comparison to the standard of care strategy, to increase adherence to cervical cancer screening. An experimental and population-based study will be implemented at three primary healthcare centers located in the Western Porto region: Cedofeita, Garcia de Orta, and Prelada. Eligible women will be randomized into a control group or an intervention group. The control group will correspond to the standard of care (invitation to screening in a clinical setting). The intervention group will be randomized into two subgroups: 1) a "directly mailed" group that will receive a self-sampling kit at their home addresses by post; 2) an "opt-in" group that will receive an invitation at home asking if they want to receive a self-sampling kit, with a pre-paid envelope to return the answer to this question. Women who answer "yes" will receive the self-sampling kit at their home addresses by post. Self-sampling samples will be subjected to HPV genotyping. In parallel, high-risk HPV positive women will be called in by their family doctors to undergo screening in a clinical setting so that they can continue their clinical follow-up in the conventional pathway.

NCT ID: NCT06284343 Not yet recruiting - Ovarian Cancer Clinical Trials

Development and Validation of a Risk Prediction Model for Venous Thromboembolism in Gynecological Cancer Patients Undergoing Systemic Antineoplastic Treatment: The Gynecological Cancer Associated Thrombosis (GynCAT) Study

GynCAT
Start date: April 1, 2024
Phase:
Study type: Observational

Cancer patients are burdened by an increased risk of venous thromboembolism (VTE), which has a significant impact on morbidity and mortality. Existing Risk Prediction Models (RPMs), including the widely accepted Khorana Risk Score (KRS), have some limitations when used in certain tumor site populations, such as gynecological cancers. Notably, gynecological patients exhibit a variable risk of VTE based on their specific tumor sites, with ovarian cancer representing the highest risk. Moreover, currently available RPMs lack validation in a broad gynecological population and may fail to effectively stratify VTE risk. GynCAT is a prospective cohort study that will be conducted on female patients with gynecologic malignancies scheduled for systemic antineoplastic treatment. During the screening phase, symptomatic VTE will be excluded, and KRS will be assessed. Pharmacological thromboprophylaxis will be considered and prescribed at clinical judgement, for patients with a KRS score of 3 or higher. Clinical, hematological, biochemical, coagulation, and genetic variables will be collected. Follow-up will last for the entire duration of the antineoplastic treatment line, and VTE events, bleeding events, and mortality will be recorded. The primary objective is the development and validation of an RPM for VTE in gynecologic cancer patients undergoing systemic antineoplastic treatment. Secondary objectives are evaluation of the predictive value of the identified model, comparing it with existing general oncology RPMs; assessment of its performance in predicting mortality; evaluation of VTE incidence in patients with KRS≥3 receiving thromboprophylaxis; identification of risk factors for bleeding in this patient population. The sample size calculation is based on an estimated VTE incidence of 5% over a mean follow-up of 12 months. Hence, a sample size of at least 1,200 patients in the derivation cohort is considered sufficient for the determination of a risk prediction model incorporating up to six predictor variables. A split-sample method will be used, with two-thirds of the study participants randomly assigned to the model derivation cohort (n=1,200) and one-third (n=600) to an independent validation cohort. The total number of patients recruited in the study will thus be of 1,800. A competing risk survival analysis with Fine & Gray model will be used to study the association between prognostic variables and VTE occurrence, considering death as a competitive risk. The RPM will be identified through a bootstrap approach to reduce the risk of overfitting. Discrimination power of the RPM will be assessed using time-dependent Receiving Operating Characteristic curve, and model calibration will be evaluated graphically and with the calculation of relative calibration slopes. In conclusion, this prospective cohort study aims to overcome the limitations of current RPMs in gynecologic cancer patients, improving the accuracy of VTE risk stratification in this population.

NCT ID: NCT06266338 Recruiting - Cervical Cancer Clinical Trials

Study of Pembrolizumab and Lenvatinib in Metastatic and Recurrent Cervix Cancer (LenPem Cervix)

Start date: March 11, 2024
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to gather information about an investigational drug combination, Lenvatinib in combination with pembrolizumab, that may help to treat cervical cancers. In this study, we are looking to see whether the combination of lenvatinib and pembrolizumab has any effect on slowing tumor growth in cervical cancer tumors.

NCT ID: NCT06263582 Not yet recruiting - Cervix Cancer Clinical Trials

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya

Start date: June 2024
Phase: Phase 1
Study type: Interventional

This study investigates the pharmacokinetics of Artesunate (AS) and dihydroartemisinin (DHA), the active metabolite of Artesunate, following intravaginal use at the dosing and frequency being studied for cervical precancer treatment. A secondary objective is to investigate safety among study participants.

NCT ID: NCT06252012 Not yet recruiting - Nurse's Role Clinical Trials

The Effect of Cervical Cancer Awareness Education Based on Mobile Application

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Cervical cancer is one of the most common cancer types affecting women in our country and in the world and causing morbidity. However, the availability of a vaccine for cervical cancer, preventable risk factors and early diagnosis tests offer a unique opportunity to reduce the rate of cervical cancer. In this context, there are studies showing that the practices developed by policies differ and that the classical health approach is insufficient. The effectiveness of the trainings given may vary according to time, place, trainer and personal characteristics of the individual. At the same time, in order to improve the attitudes and behaviours of individuals in terms of prevention and early diagnosis of cervical cancer, awareness of individuals about cervical cancer should be increased. In this way, women will have a say about their own health and their conscious participation in health care services will be realised. Therefore, the aim of this project is to apply cervical cancer awareness training to women and to examine its effect on women's cervical cancer prevention and early diagnosis behaviours. Original value; The fact that there is no mobile application developed for cervical cancer in Turkey reveals the national value of the research. In addition, the mobile application has international unique value as it is the first mobile application structured to provide awareness on cervical cancer prevention and early diagnosis behaviours. The project method was planned for the development and implementation of the mobile application programme. The research design will be a randomised controlled study. The 120 women who meet the inclusion criteria and who apply to more than one family health centre will be randomly assigned to the intervention and control groups. The effect of the mobile application programme on women's attitudes and behaviours towards cervical cancer prevention and early diagnosis will be evaluated at the 6th and 12th weeks. In the evaluation of the data, t-test for independent groups, anova and chi-square tests will be used to measure the effect of the intervention. Widespread effect; In this way, it is planned to reduce the time spent by professionals for care-related activities, to strengthen time management, to provide advantages and improvements in the performance of nurses in patient care management by using technological resources in the health care provided.

NCT ID: NCT06215950 Recruiting - Ovarian Cancer Clinical Trials

A Clinical Research About CD70-targeted CAR-T in the Treatment of CD70-positive Advanced/Metastatic Gynecologic Cancer

Start date: January 10, 2024
Phase: Phase 1
Study type: Interventional

This is a single-center, double-arm, open-label study. this study plans to evaluate the safety and efficacy of CD70-targeting CAR-T cells in the treatment of CD70-positive advanced/metastatic Gynecologic Cancer, and obtain recommended doses and infusion patterns.

NCT ID: NCT06196190 Recruiting - Cervix Cancer Clinical Trials

Prognostic Value of Conization and Negative HPV After Conization in AIS and Early Stage Cervical Cancer

Start date: July 26, 2023
Phase:
Study type: Observational

In women with cervical cancer -Squamous cell carcinoma, Adeno carcinoma, Adeno-squamous carcinoma or AIS we want to examine prospectively: 1. Examine if negative HR-HPV after conization to the HR-HPV the women had before conization has a high prognostic value for no residual tumor in the final pathology. 2. To examine if conization in women with cervical tumor up to Stage I B 2 (FIGO 2018) is corelated with better prognosis.