Evaluation of Nu.Q™H3.1 Test in K2-EDTA Plasma Obtained from Normal Subjects and Subjects with Relevant Benign Conditions (“NORBEN”) [Protocol # VOL-003]
This clinical study and associated specimen collection study will be conducted to assess the performance of the Volition America, Inc. Nu.Q™H3.1 in vitro diagnostic test (Test) for use as an aid in the assessment of subjects suspected of Non-Hodgkin Lymphoma (NHL) prior to diagnosis. The Test is intended to be used by healthcare professionals for the quantitative measurement of histone H3.1 nucleosome in K2 EDTA plasma.
Three studies will be conducted to support the development of the Test and to define its intended use. This sub-protocol is for the second pre-pilot study. The goal will be to assess the performance of the Test on subjects in an apparently healthy population (but otherwise like the intended use population in terms of demographics) and then in benign conditions particularly relevant for NHL and other benign conditions possibly having elevated nucleosomes. We refer to this study as the NORBEN study signifying the study of normal and benign subjects. A key aspect of diagnostic performance is specificity. Namely, the ability to say an individual does not have NHL when that is true. It will be important that individuals with no serious comorbidities to test negative using the Test. In addition, the Test needs to be able to distinguish subjects at high risk of NHL and no NHL from subjects with such comorbidities (e.g., autoimmune diseases such as rheumatoid arthritis and lupus; chronic infections such as HIV and HCV, etc.) from those who may have the condition but also have NHL.
This pre-pilot study will be used to refine the intended use and the intended use population and design the protocol for the final study. The final study will have a pilot phase and pivotal phase. In this final study subjects will be enrolled based on symptoms at presentation to a physician. This is quite distinct from this pre-pilot study where subjects already have been diagnosed. This study is aligned as much as possible with the intended use of the Test. It will include testing all steps from the time an initial specimen is taken from a subject, procedures for processing and shipping specimens to the designated laboratory for testing and finalizing the Test result for each specimen. This study may include different types of clinical settings including general practice, rheumatoid/immunology practices, gerontology, hematology settings, and emergency room settings.
Clinical data that already is part of routine care will be collected. This study is not considered a significant risk to participating subjects.
Please click on the link below to see if you qualify to participatehttps://www.surveymonkey.com/r/53P8K8H