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Uterine Cervical Neoplasms clinical trials

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NCT ID: NCT04461678 Active, not recruiting - Cervical Cancer Clinical Trials

Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit

Start date: August 23, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic Acid Assay Kit. This is a multi-center clinical study involving at least three study centers, each with screening sites. The protocol describes two study phases: Phase I is a baseline study of the screened population and ASCUS referral population (if necessary), the data of which will be submitted after the baseline study is completed; Phase II is a three-year follow-up study of the screened population, the data of which will be submitted again after the follow-up is completed.

NCT ID: NCT04461574 Recruiting - Cervical Cancer Clinical Trials

Orcellex® Brush Versus Cervex-Brush® on Vault Smear Adequacy in Patients Treated With Radiotherapy for Cervical Cancer

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

Vaginal vault cytology is commonly used for follow-up surveillance in patients treated for cervical cancer. It is known that the smear inadequacy rate is high, especially in patients post-radiotherapy at 10%. The current practice is to use Cervex-Brush®, which was designed for cervical smear taking. Cervix will shrink into a dimple with a flat vaginal vault and vagina may be stenotic after radiotherapy, rendering the use of the conventional sampling device difficult. Orcellex® Brush was designed to collect cells from oral mucosa, with high patient satisfaction and low smear inadequacy of 1% in one study. As both the vaginal vault mucosa and oral mucosa are flat surface lined with stratified squamous epithelium, the use of Orcellex® Brush in vaginal vault smear appeared applicable. It has a smaller head with a flat surface of hair, which might better fit the flat vault surface and narrow vaginal canal. It is postulated that the Orcellex® Brush helps in improving vaginal vault smear adequacy rate in patients after radiotherapy treatment for cervical cancer.

NCT ID: NCT04453241 Completed - Cervical Cancer Clinical Trials

Immunogenicity and Safety Study of NBP615 in Healthy Female

Start date: December 22, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.

NCT ID: NCT04426019 Completed - Breast Cancer Clinical Trials

Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women

Start date: January 12, 2012
Phase: N/A
Study type: Interventional

The primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.

NCT ID: NCT04423679 Recruiting - Cervical Cancer Clinical Trials

The Selfie Study- Assessing Novel Markers for Cervical Cancer Screening From Self-collected Samples

SELFIE
Start date: August 15, 2020
Phase:
Study type: Observational

Cervical cancer is primarily caused by Human Papillomaviruses (HPV). Testing for HPV in cervical samples is now an option for cervical cancer screening. HPV can also be tested from self-collected samples which may help to improve access to screening, since it does not require a doctor visit. However, many women will test positive for HPV who are not at high risk for cervical cancer. Therefore, additional ("triage") tests are needed to determine which women testing HPV-positive require additional clinical workup. For self sampling, a triage test that could be measured from the same initial sample without requiring a follow-up visit to the doctor would be an ideal strategy. The purpose of this study is to determine whether a new HPV test that measures changes in HPV DNA can be used to triage HPV-positive women using self collected samples. This study will enroll 1,000 women who are undergoing cervical cancer screening at the George Washington University. Women will be asked to take a self-collected sample prior to their clinic visit. The investigators will evaluate the clinical accuracy of the new HPV triage test in self-collected samples and compare the accuracy of the test in samples collected by the clinician.

NCT ID: NCT04421131 Completed - Cervical Cancer Clinical Trials

mHealth-supported Telecolposcopy for Cervical Cancer Programs in Low-resource Settings: Evaluation (mIVAA)

Start date: January 8, 2021
Phase: N/A
Study type: Interventional

The central hypothesis is that use of mIVAA (mobile Inspección Visual con Ácido Acético - Spanish for Visual Inspection with Acetic Acid (VIA)) will increase the proportion of VIA positive women who complete follow-up clinical evaluation compared to VIA positive women in situations in which mIVAA was not used, thus potentially improving cervical cancer treatment and survival rates. The study will collect qualitative and quantitative data to examine the feasibility and preliminary impact of mIVAA on reducing attrition for follow-up clinical evaluations.

NCT ID: NCT04409860 Recruiting - Cervical Cancer Clinical Trials

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

CQGOG0102
Start date: May 26, 2020
Phase: N/A
Study type: Interventional

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

NCT ID: NCT04405349 Completed - Cervical Cancer Clinical Trials

Investigating the Combination of VB10.16 and Atezolizumab in Patients With HPV 16-positive Cervical Cancer

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

This phase IIa study is designed to evaluate the safety and efficacy of multiple dosing with VB10.16 immunotherapy in combination with atezolizumab in patients with advanced or recurrent non-resectable HPV16-positive cervical cancer, who failed or are not eligible for current standard of care.

NCT ID: NCT04403867 Recruiting - Cervical Cancer Clinical Trials

The Role of Micrometastasis and Isolated Tumor Cells (ITCs) in Endometrial and Cervical Cancer. A Multicenter Study.

ITCMicroUtCa
Start date: January 2, 2020
Phase:
Study type: Observational

The role of small-volume lymph node disease (ITC and micro metastases) among patients with endometrial or cervical cancer submitted to sentinel node (SLN) procedure is not clearly defined. This study was designed to create a dataset of patients with lymph nodal disease. Data on type and volume of lymph nodal disease, therapeutic choices and oncological outcomes (DFS, OS, recurrence rate) will be collected and analyzed. This will allow to define the groups of patients who may need or for whom it can be avoided any adjuvant treatment on the basis of lymph node status.

NCT ID: NCT04401670 Completed - Cervical Cancer Clinical Trials

Cervical Cancer Screening in Cameroon

Start date: April 25, 2017
Phase: N/A
Study type: Interventional

Human immunodeficiency virus-infected (HIV[+]) women have a several-fold increased risk of invasive cervical cancer (ICC) as well as increased risk of cervical pre-cancer. In low- and middle-income countries (LMICs), ICC is the 1st or 2nd most common cause of cancer and cancer-related death in women. Rates of ICC and ICC-related mortality are particularly high in Sub-Saharan Africa, which also has the highest rates of HIV infection in the world. Although prophylactic HPV vaccines may be the optimal cervical cancer prevention strategy, 2-3 generations of at-risk HIV[+] and HIV[-] women are already highly exposed to human papillomavirus (HPV) and would not benefit from (and will not be immunized with) HPV vaccine. Thus cervical cancer screening is needed for the foreseeable future. However, Pap testing is expensive and requires a complex clinical and lab infrastructure that does not generally exist in LMICs; strategies based on high-risk HPV (hrHPV) testing or visual inspection after acetic acid (VIA) are promising but are either too non-specific, leading to over-referral for colposcopy or over-treatment, or are too insensitive, respectively. Thus, inexpensive, easily implemented, and effective cervical cancer screening methods are greatly needed in Sub-Saharan Africa, especially for HIV[+] women. This cervical cancer screening study of 1,200 women (800 HIV[+] and 400 HIV[-] women), aged 25-59 years, living in Cameroon, utilized our existing research site. The investigators evaluated screening tests (hrHPV testing, VIA and Pap), traditional triage tests (HPV16/18/45 detection, VIA, Pap), and promising new biomarkers for triage (Ki-C67, TOP2a, CDKN2A, and HPV viral load) of screen-positive women. All screen positives underwent rigorous disease ascertainment to obtain unbiased estimates of sensitivity, specificity, and positive and negative predictive value. The goal of this study was to establish the foundation and capacity for future studies designed to reduce the burden of HPV-associated cancers in the Cameroon population. It will inform Cameroon and other countries with high HIV burdens on the best strategies for cervical cancer screening in their HIV[+] and HIV[-] women.