close

Clinical Trials

Date: 2011-07-09

Type of information: Initiation of preclinical development

phase: prospective study

Announcement: initiation

Company: VolitionRX (Singapore) - Rheinische Friedrich-Wilhelms-Universität Bonn (Bonn University - Germany)

Product: NuQ™ and NuQ-X™ tests

Action mechanism:

NuQ™ and NuQ-X™ tests belong to a range of blood-based epigenetic cancer early detection tests. These tests are used for the detection of the level of nucleosomes in a patient’s blood. The above tests are being developed to work together:  The basic NuQ test will be used as a frontline test for the level of nucleosomes in the blood. If the results of this test are negative, there is likely no cancer and further testing is not immediately required. If the results of the NuQ test are positive, the patient may have cancer or another condition so further testing will be required to a) confirm whether the patient has cancer or another condition; and b) if there is cancer, to determine the specific subtype of cancer
This will be done using the NuQ-V tests and the NuQ-M test in conjunction (collectively called the “NuQ panel”).
NuQ-X™ is a family of blood tests for the detection of nucleosomes containing specific nucleotides.

Disease:

Therapeutic area: Cancer - Oncology

Country: Germany

Trial details:

Bonn University’s multiple clinical trials will evaluate the performance of VolitionRX’s NuQ tests. The trials will be in three parts:
1. A two month pilot study, using retrospectively-collected patient blood samples;
2. A large multi-year prospective study, during which blood samples will be initially collected from patients at University Hospital Bonn; and
3. A validation of the tests as a predictor of the performance and therapy monitoring of chemotherapy.
The pilot study will be an early clinical evaluation of VolitionRX’s proprietary NuQ and NuQ-X tests on 4000 retrospectively-collected patient samples, both from cancer patients and controls (healthy patients). It will provide an early initial evaluation of the diagnostic performance of the tests and correlation of the results with disease characteristics. The trials will be in three parts:
1. A two month pilot study, using retrospectively-collected patient blood samples;
2. A large multi-year prospective study, during which blood samples will be initially collected from patients at University Hospital Bonn; and
3. A validation of the tests as a predictor of the performance and therapy monitoring of chemotherapy.
The pilot study will be an early clinical evaluation of VolitionRX’s proprietary NuQ and NuQ-X tests on 400 retrospectively-collected patient samples, both from cancer patients and controls (healthy patients). It will provide an early initial evaluation of the diagnostic performance of the tests and correlation of the results with disease characteristics.

During the prospective study, which will commence in July 2012, blood samples will be taken from at least 2000 patients including:
1. Healthy individuals
2. Patients with cancers (age- and gender-matched) including:
•    Twenty of the most prevalent major organ and hematological cancers
•    Diverse stages
•    Diverse histologies
•    Clinical characteristics
3. Patients with other conditions including:
•    Organ-related benign diseases
•    Metabolic diseases such as renal failure and autoimmune disease
•    Acute diseases such as sepsis, inflammation, trauma and stroke
•    Chronic degenerative diseases

The trial will evaluate the performance of VolitionRX’s tests including all methodical aspects that are relevant for their application in clinical testing and potentially influencing factors in problematic samples. It will also evaluate the influence of preanalytic conditions on the tests, particularly the pre-analysis treatment of the blood samples.
A separate clinical evaluation will be carried out on chemotherapy patients, to evaluate the NuQ tests’ validity for therapy monitoring and response prediction. Samples will be collected from approximately 300 patients with a range of cancers. The samples will be collected before each of the 6 to 8 therapy cycles and will be correlated with the radiological response evaluation. For both clinical scenarios, the NuQ tests will be compared with already established tumor markers to see their specific use in the clinical application.

Latest news:

* On May 8, 2015, VolitionRx, a life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, announced that it has accelerated its large independent prospective study evaluating its proprietary Nucleosomics® platform at University Hospital Bonn in Germany. VolitionRx has dedicated two of its recently-procured Tecan EVO200 automated laboratory robots to the study, with sample analysis to begin early in the third quarter of 2015. In addition, VolitionRx and study lead Prof. Stefan Holdenrieder at the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn in Germany have increased the sample size and breadth of cancer types being tested.

The study initially included 4,000 patient blood samples across 20 of the most prevalent cancer types, and has now been expanded to include approximately 4,200-patient blood samples across 27 of the most prevalent cancers, including: two types of respiratory cancer, seven types of gastrointestinal cancer, four gynecological cancers, four urinary cancers, four types of hematological cancer, plus melanoma, sarcoma and cancers of the thyroid and brain; as well as control patients with 24 other conditions and healthy individuals. In total, the cancer types being analyzed represent over 95% of the incidence of cancer. VolitionRx expects to analyze the samples with up to 10-15 NuQ® assays by the first quarter of 2016. 

* On July 9, 2011, VolitionRX has entered into a collaboration agreement with Rheinische Friedrich-Wilhelms-Universität Bonn (Bonn University). Under the agreement, Dr. Stefan Holdenrieder of the Institute of Clinical Chemistry and Clinical Pharmacology at University Hospital Bonn will undertake multiple independent clinical trials of VolitionRX’s NuQ™ assays. VolitionRX will also engage the German statistical firm, QuoData, which has specific expertise in multiparametric and kinetic analyses, to undertake mathematical and statistical evaluation of the results of the studies.

 

 

Is general: Yes