A multiplex assay for early detection of Cutaneous T-Cell Lymphoma

Abstract
The ultimate goal of the proposed research is to develop a multiplex assay for early detection of
Cutaneous T Cell Lymphoma CTCL in human serum or plasma Mycosis fungoides MF is a slowly
progressive form of CTCL that initially manifests by non specific cutaneous eczematous patches and plaques
similar to atopic dermatitis eczema psoriasis and other benign dermatoses The early diagnosis of MF is
frequently delayed by many years and many patients with early MF remain unrecognized delaying appropriate
therapy resulting in poor outcomes Numerous attempts to improve diagnostic accuracy in early stage disease
have been made Early diagnosis is particularly challenging due to absence of definitive markers for the
disease including unreliable clonality studies in early stages
Using a high throughput bead based Luminex xMAP multiplexing technology Dr Geskin and colleagues
have screened patients with MF for numerous potential biomarkers across all stages and compared them to
normal controls HIV patients and patients with benign dermatoses in the age matched fashion They were
able to demonstrate a distinct immune profile in patients with MF Furthermore measuring concentrations of a
panel of several biomarkers in human plasma or serum would provide high sensitivity and specificity for
distinguishing early stage MF from non MF controls
Our goal is to develop a non invasive simple multiplex assay based screening test which is capable of
selecting the individuals at high risk for cutaneous lymphoma among people with benign dermatoses before
they develop advanced disease Once a high risk group is selected then an in depth evaluation could be
performed by diagnostic specialists
The Specific Aims of this Phase I project are
To compare the performance of a multiplex assay for determination of several biomarkers in human plasma
or serum with the corresponding singleplex ELISAs
To show the feasibility of the multiplex assay for early detection of CTCL in human serum or plasma using a
limited number of clinical samples Narrative
The development of the proposed method will allow for early detection of Cutaneous T
Cell Lymphoma CTCL in human serum or plasma Successful completion of these
studies will be beneficial for public health and make available all of the technology
needed for a substantial business opportunity to license the technology and manufacture
commercial products