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A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects

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…

Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer

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…

Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.

1. To study the safety and feasibility of para-aortic surgical staging in advanced cervical cancer in the Netherlands.2. To provide insight in the possible effectiveness of para-aortic surgical staging in advanced cervical cancer as compared to…

A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals* HPV 16/18 L1/AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy adult female subjects aged 26 years and above.

* 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…

The long-term immune response after HPV16 peptide vaccination in woman with low-grade pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

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…

The effect of HPV16 peptide vaccination on the local immune response in woman with high grade HPV16+ pre-malignant disorders of the uterine cervix, a placebo controlled phase II study

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.…

MeD-seq, a novel assay for genome-wide DNA methylation profiling in developing predictive biomarkers of gynaecological cancer and endometriosis

1. To study the possibility to detect gynaecological malignancies and endometriosis in Pap smears and blood of women with gynaecological cancer or endometriosis, using MeD-seq and biomarker assays, in order to develop new reliable screening methods…

A RANDOMIZED TRIAL COMPARING RADICAL HYSTERECTOMY AND PELVIC
NODE DISSECTION VS SIMPLE HYSTERECTOMY AND PELVIC NODE DISSECTION
IN PATIENTS WITH LOW RISK EARLY STAGE CERVICAL CANCER

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…

A double blind, prospective, randomized, placebo controlled, multi-center phase 3 study to evaluate efficacy and safety of Cevira® in patients with cervical histologic high-grade squamous intraepithelial lesions (HSIL)

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.

The RACC trial -Robot-assisted Approach to Cervical Cancer. A multi-centre open-label randomised non-inferiority trial of robotassisted laparoscopic surgery versus laparotomy in women with early stage cervical cancer.

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).

Phase 3 study of ADXS11-001 administered following chemoradiation as adjuvant treatment for high risk locally advanced cervical cancer: AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence)

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…

Reliability, validation and acceptance of a novel self-lavaging collection device, MySampleTM, in combination with the HPV-Risk Assay and QIAsure Methylation test to screen for cervical cancer.

This study is to answer two questions. First the reliability and validity of the novel lavage method to screen on cervical cancer in combination with the clinically validated hrHPV and hypermethylation triage tests. Second the functionality and…