18 results
To provide clinical management and, if required, treatment to subjects who at their concluding HPV-015 study visit displayed normal cervical cytology but tested positive for oncogenic HPV infection or who were pregnant at their concluding visit of…
To establish the changes in tumour diffusion hyperthermia induces in humans.
Our primary objective is to determine whether testing for molecular markers, i.e. hrHPV, methylationmarkers , i.a. CADM1/MAL and combinations thereof, yields a higher sensitivity and specificity for the detection of CIN2/3 or cancer after treatment…
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.
To identify molecular alterations associated with cervical tumorigenesis, that could be used as biomarker for improving detection and differentiation between cervical cancer, cervical intraepithelial neoplasia and normal cervical tissue.
This study will be conducted to determine the overall hr-HPV agreement between self-sampled cervicovaginal smear (Evalyn Brush) and physician-obtained samples taken by a trained physician (liquid based cervical smear) in a screening population. The…
* To demonstrate efficacy of the candidate vaccine in the prevention of (1) persistent infection (6-month definition) with HPV-16 or HPV-18 (by polymerase chain reaction [PCR]) and/or (2) histopathologically-confirmed CIN1+ associated with HPV-16 or…
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
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.
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…