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Vulvar Neoplasms clinical trials

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NCT ID: NCT04985357 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Defining the Clinical Potential of Mass Response as a Biomarker for Patient Tumor Sensitivity to Drugs

Start date: June 2024
Phase:
Study type: Observational

The primary objective of this study, sponsored by Travera in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from varying cancers and biopsy formats.

NCT ID: NCT04977453 Recruiting - Clinical trials for Non-small Cell Lung Cancer

GI-101 as a Single Agent or in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Advanced Solid Tumors

Start date: August 2, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab, lenvatinib or local radiotherapy (RT) over a range of advanced and/or metastatic solid tumors.

NCT ID: NCT04952961 Completed - Vulvar Cancer Clinical Trials

Early Detection of Vulval CAncer Through Self-Examination (EDuCATE): Intervention Study

Start date: November 4, 2021
Phase: N/A
Study type: Interventional

Vulval cancer, while rare, has increased in incidence by 17% since the 1990s. It is strongly associated with age, thus this increasing trend is likely to continue with extended life expectancy. Vulval cancer is highly treatable when detected early. Women with chronic vulval conditions including lichen sclerosus, lichen planus and vulval intraepithelial neoplasia are at increased risk of developing vulval cancer. Most patients are in hospital follow-up, however regular vulval self-examination can pick up lesions earlier. There are no formalised methods of teaching self-examination and no evidence that it is acceptable to women. The main objective of this study is to pilot an intervention to promote and support vulval self-examination for women at increased risk of vulval cancer including those with lichen sclerosus, lichen planus and vulval intraepithelial neoplasia. Findings from this feasibility study will inform the design of a randomised trial comparing the interventions versus control with an embedded cost-effectiveness analysis.

NCT ID: NCT04905030 Enrolling by invitation - Cervical Cancer Clinical Trials

Education, Immigration and HPV Vaccination: an Informational Randomized Trial

Start date: April 28, 2021
Phase: N/A
Study type: Interventional

Counteracting misinformation on childhood vaccines remains a priority for public health in industrialized countries. Previous research showed that misinformation-induced vaccine hesitancy particularly concerns very highly or very lowly educated parents, and, especially in Europe, specific groups of immigrants. Misinformation framing directly targets specific sub-population of parents by exploiting different cognitive biases, and specific concerns based on cultural norms: this project aims at testing the effectiveness of similar framing techniques applied to positive information on the HPV vaccine by conducting a Randomized Controlled Trial in Stockholm, Sweden. It randomizes emotionally and scientifically/statistically framed information addressing the specific concerns reported by previous literature.

NCT ID: NCT04895020 Recruiting - Cervical Cancer Clinical Trials

Immunobridging Study of 9-valent Human Papillomavirus Recombinant Vaccine in Chinese Females Aged 9 to 19 Years

Start date: May 28, 2021
Phase: Phase 3
Study type: Interventional

This phase 3 study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese females aged 9 to 45 years

NCT ID: NCT04761146 Recruiting - Vulva Cancer Clinical Trials

A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

DaRT-V
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

An investigation to investigate the use of diffusing alpha-emitters radiation therapy (DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva.

NCT ID: NCT04713618 Active, not recruiting - Clinical trials for Endometrial Carcinoma

Changes in Pelvic Health, Sexual Function, and Quality of Life in Women With Pelvic Cancer Undergoing Radiation Therapy

Start date: January 30, 2021
Phase:
Study type: Observational

This study investigates changes in physical measures of pelvic health and patient-reported outcomes of sexual function, intimate relationship, and quality of life over time in women undergoing radiation therapy for pelvic cancer. Evaluating vaginal changes prior to and after a course of radiation and collecting patient reported outcomes of sexual function, partner communication, and intimacy may help researchers may help researchers better understand physical changes and symptoms over time.

NCT ID: NCT04708470 Recruiting - Cervical Cancer Clinical Trials

A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers

Start date: October 5, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with NHS-IL12 and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get NHS-IL12 as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.

NCT ID: NCT04663412 Recruiting - Vulvar Cancer Clinical Trials

Indocyanine Green Fluorescence Imaging, Sentinel Lymph Node Mapping in Patients With Vulvar Cancer

Start date: July 9, 2020
Phase: N/A
Study type: Interventional

The potential of the administration of indocyanine green (ICG) allows the execution of SLN biopsy, avoiding the multiple administrations of radiocolloid in the pre-operative phase, painful for the patient, elimination, and exposure to radioactivity. Therefore, while requiring standardization of the methodology and a large-scale application, this procedure could open a new surgical management perspective in patients with early-stage vulvar cancer.

NCT ID: NCT04541784 Completed - Vulvar Neoplasm Clinical Trials

Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Despite great advances in surgical therapy in the last decades, symptom relief for women with vulvar neoplasia (vulvar cancer and pre-stage of vulvar cancer) is still not optimal. Guidelines of the National Comprehensive Cancer Network recommend using electronic communication media, e.g. applications ("apps") to relieve symptom distress and foster self-management. However, little is known on how effective these communication technologies are, especially in the field of a rare cancer disease like vulvar neoplasia. This mixed methods project aims to examine the effectiveness of a multidimensional mobile app intervention ("WOMAN-PRO III") focusing on possible improvements due to the new mobile app intervention, which consists of three counselling sessions with a gynaecologic-oncology nurse and the use of the mobile app whenever women want for a period of six months, the online version of the "WOMAN-PRO" diary for symptom assessment, the opportunity to send the data to the gynaecology-oncology nurse, disease and treatment related information and evidence-based recommendations, relevant contact data and a chat function for the anonymous exchange with peers (intervention group) compared to three counselling sessions with a gynaecologic-oncology nurse, where they receive written information (control group). Effectiveness will be examined with respect to symptom induced distress, uncertainty and cost effectiveness in women with vulvar neoplasia after surgical treatment across time. The objective of the qualitative study is to assess women's perceived uncertainty and the acceptability, usability, strengths and weaknesses of the mobile app intervention ("WOMAN-PRO III") from patients' and gynaecology-oncology nurses' perspective.