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Vulvar Neoplasms clinical trials

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NCT ID: NCT05853549 Completed - Vulvar Cancer Clinical Trials

Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer

Start date: March 18, 2022
Phase: N/A
Study type: Interventional

This prospective study evaluated the clinical implementation value of an optical surface monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup

NCT ID: NCT05529303 Completed - Ovarian Cancer Clinical Trials

Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients

Start date: February 26, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the effect of the 'Feminine Identity Improvement Program', based on cognitive behavioral and expressive techniques applied to gynecological cancer patients, on prolonged grief reactions and the perception of femininity. The study will be conducted in a randomized controlled and qualitative type with gynecological cancer patients who completed their surgical treatment at least three months ago in the last year at Afyonkarahisar Health Sciences University Hospital.

NCT ID: NCT05372016 Completed - Cervical Cancer Clinical Trials

Evaluate the Immunogenicity and Safety of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Start date: September 19, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the immunogenicity and safety of 9-valent HPV recombinant vaccine in Chinese healthy females16 to 26 years of age.

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: 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.

NCT ID: NCT04425291 Completed - Cervical Cancer Clinical Trials

Evaluate the Immunogenicity and Safety of 4-valent and 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Start date: May 28, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the immunogenicity and safety of 4-valent and 9-valent HPV recombinant vaccine in Chinese healthy females 20 to 45 years of age.

NCT ID: NCT04351139 Completed - Gynecologic Cancer Clinical Trials

Impact of the COVID-19 Pandemic in Gynecological Oncology

COVID-GYN
Start date: May 6, 2020
Phase:
Study type: Observational

The current infection with the Coronavirus SARS-CoV-2 (COVID-19) is an exceptional health situation which requires an adaptation of our management practices in gynecological oncology. Data from the literature suggest that infection with Coronavirus is serious in subjects with cancer with a risk of severe form 5 times higher than that of the population without cancer and a risk of death multiplied by 8. In addition, the risk of infection would be 3 times greater in case of cancer. Faced with the COVID-19 epidemic, the investigator must organize themselves to ensure continuity in the treatment of patients with gynecological cancer but also adapt our practices in the management (CPR, teleconsultation, adaptation of treatment or even postponement of treatment). The objective of the High Council of Public Health is to be able to ensure adequate oncological care avoiding any potential loss of chance concerning the care of cancer: people affected must, despite the pandemic, have care allowing the same level of curability (localized cancers) or the same life expectancy (advanced cancers). This must be done by limiting as much as possible the impact on the organization of the service, the organization of patient follow-up and the psychological impact that these possible modifications could have. The hypotheses of our study are that the exceptional health situation linked to this pandemic leads to a change in the care of patients with gynecological cancer associated with a psychological impact and increased anxiety of patients during their care. Despite the extent of the pandemic, very little existing data makes it possible to define recommendations with a sufficient level of evidence.

NCT ID: NCT04269837 Completed - Clinical trials for Malignant Female Reproductive System Neoplasm

Sexual Health Counseling Intervention During Radiation Therapy in Improving Quality of Life for Women With Gynecologic Cancer

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

This phase I trial studies a sexual health counseling intervention during radiation therapy in improving quality of life for women with gynecologic cancer. Women with gynecologic cancer often suffer long-term complications from treatment that can affect their physical and psychological well-being. An early sexual health counseling intervention prior to and after radiation may improve symptoms management and reduce the physical and psychological effects of treatment.

NCT ID: NCT04147780 Completed - Sentinel Lymph Node Clinical Trials

Sentinel Node Extended in Squamous Cell Vulvar Cancer

SNEX
Start date: December 14, 2019
Phase:
Study type: Observational

The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

NCT ID: NCT03849469 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors

DUET-4
Start date: May 29, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, multiple dose, ascending-dose escalation study and expansion study designed to define a maximum tolerated dose and/or recommended dose of XmAb22841 monotherapy and in combination with pembrolizumab; to assess safety, tolerability, pharmacokinetics, immunogenicity, and anti-tumor activity of XmAb22841 monotherapy and in combination with pembrolizumab in subjects with select advanced solid tumors.