17 results
To establish the changes in tumour diffusion hyperthermia induces in humans.
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
To investigate whether hyperthermia induces HR-deficiency in cervical tumors and as a feasibility study, secondly to investigate whether it is possible to detect circulating tumor cells before and after hyperthermia.
The aim of the vaginal morbidity sub-study is to better understand the different physical, dosimetric, biological, clinical and psychological factors and to analyse the importance of these factors for patient reported outcome on sexual functioning…
Implement a survey initiative to assess HIV prevalence for one or more diseases and/or conditions within a specific segment of the population not yet diagnosed with HIV and that present for care with the specific disease/condition.
Evaluation of the capacity of a HPV 16 peptide vaccine to install a long term HPV-specific T cell response, to define the importance of a booster vaccine after 1 year, the induction of Cytotoxic T lymphocyte (CTL) immunity against HPV16E6 and E7 and…
This study aims to reveal whether vaccination of women with HPV 16+ cervical intraepithelial neoplasia not only results in a strong systemic T-cell response, but also endows these T-cells with the capacity to infiltrate HPV16-induced lesions.…
To evaluate the impact of treatment of undetected, asymptomatic, predefined uterine abnormalities on the success of IVF treatment
Primary objectives:- Evaluate colposcopic visual appearance of cervical lesions in relation to its histological substrate, HPV genotype(s) and molecular parameters.- Study cervical disease on the lesion level using HPV genotyping and other viral…
To evaluate whether a less radical surgical approach with sentinel lymph node biopsy is non-inferior to treatment with systematic pelvic lymphadenectomy.The null hypothesis is that the recurrence rate after SLN biopsy is non-inferior to the…
Primary objective:To evaluate whether treatment with simple hysterectomy and pelvic node dissection is non-inferior to treatment with radical hysterectomy and pelvic node dissection in terms of pelvic relapse-free survival.Secondary objectives:To…
The objective of this study is to establish the effectiveness and confirm the safety of the VizAblate System in ablating symptomatic uterine fibroids.
1. What is the level of psychological distress among cervical cancer patients over time?2. What is the role of characteristics of the individual, characteristics of the environment, biological function, overall quality of life, functional status and…
The purpose of the study is to evaluate the efficacy and safety of Cevira® compared to placebo in treatment of patients with cervical histologic HSIL.
In the proposed project, we will conduct a clinical phase I trial with cervical cancer patients, scheduled to undergo radical hysterectomy and pelvic lymphadenectomy, to assess the safety and toxicity as primary endpoints and, as an explorative…
We aim to demonstrate that robot-assisted laparoscopic radical hysterectomy is non-inferior to conventional laparotomy in recurrence free survival of patients with early stage cervical cancer (stage 1B1, 1B2 and 2A1).
Primary objective:- Disease free survival (DFS)Secondary objective:- Safety & tolerability- Overall survival (OS)Exploratory objective:- Association between HPV subtypes and efficacy- Patient reported outcomes (PRO)Please refer to section 1…