The Myeloid Neoplasms Biology and Outcome Project (MyBOP) aims to establish a registry
study for patients with myeloid neoplasms. It integrates clinical data, biological
samples, socio-demographic information, long-term follow-up and patient reported outcomes
in a structured manner for scientific purposes.

The ultimate benefits are:

  1. Improvement of evidence-based clinical management of patients with myeloid neoplasms
     through better understanding of the course of disease and prognostic and predictive
     parameters

  2. Direct access to new and personalized treatment approaches through recruitment into
     clinical studies based on the myeloid neoplasms study platform

  3. Quality assurance of participating centers by evaluating and comparing clinical
     outcomes and side effects of the MyBOP patients with published data.

The Myeloid Neoplasms Biology and Outcome Project

Myeloid Neoplasm

During recent years, considerable progress has been made in deciphering the molecular
genetic and epigenetic basis of myeloid neoplasms and in defining new diagnostic and
prognostic as well as predictive markers. Myeloid neoplasms are categorized according to
the current WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues based on
the revision of 2016 [1]. This includes Myeloproliferative neoplasms (MPN), Mastocytosis,
Myeloid/lymphoid neoplasms with eosinophilia and rearrangement of PDGFRA, PDGFRB, or
FGFR1, or with PCM1-JAK2, Myelodysplastic/myeloproliferative neoplasms (MDS/MPN),
Myelodysplastic syndromes (MDS), Myeloid neoplasms with germ line predisposition, Acute
myeloid leukemia (AML) and related neoplasms (i.e. Myeloid sarcoma and Myeloid
proliferations related to Down syndrome), Blastic plasmacytoid dendritic cell neoplasm
and Acute leukemia of ambiguous lineage (Table 1).

A growing number of recurring genetic changes are recognized in the current WHO 2016
classification of myeloid neoplasms [2] and additional molecularly defined subgroups as
well as new entities are expected to be included in future versions. Furthermore, novel
therapies are now available and being developed, which target specific genetic lesions,
and several surface antigens are being explored as targets for immunotherapy-based
treatment strategies, e.g. CAR-T-cell therapy [3].

Although the WHO 2016 classification represents an enormous progress in terms of
reliability, validity and objectivity, there are still huge diagnostic uncertainties left
[4-18] and the field of targeted therapy [19-25] in myeloid neoplasms is just at its
beginning. Furthermore, clonal evolution and transition from one entity to another is a
clinically relevant issue [26-30].

Thus, key areas of interest are:

  -  Systematic collection and evaluation of comprehensive clinical information from
     patients with myeloid neoplasm, including morphomolecular disease subtype, as well
     as drug treatments, radiation therapy, surgical procedures and long-term follow-up
     data

  -  Systematic collection and evaluation of comprehensive biological specimens and
     information from patients with myeloid neoplasms, including data on the genomic,
     transcriptomic, epigenomic and proteomic "landscapes" as well as expression of
     surface antigens of myeloid disease subtypes, to identify novel prognostic and
     predictive parameters as well as entry points for targeted therapeutic interventions

  -  Regular assessment of patient reported outcomes

The above challenges are ideally met by a registry study with a sufficient population
size in order to answer relevant questions in rare cancer entities. The aim is to set up
a registry study that covers systematic and comprehensive clinical data acquisition. In
addition, the banking of tumor and germline samples from patients with myeloid neoplasms
is intended by all patients. This resource will spur patient-oriented investigations into
relationships between clinical and biological parameters in myeloid neoplasms and lay the
groundwork for novel, molecular mechanism- and immunotherapy-based treatment approaches
in poorly understood and difficult-to-treat subsets.

A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients With Myeloid Neoplasms

Time period of survival from date of diagnosis of myeloid neoplasy

Time period of event free survival from date of diagnosis of myeloid neoplasy

Time period of progression survival from date of diagnosis of myeloid neoplasy

Head of NCT trials center and Clinical Trials Office Hematology/Oncology

Standardized Quality of Life Assessment, Higher values are better

Standardized Quality of Fatigue, Higher values are worse

Standardized Quality of anxiety and depression, Higher values are worse

Standardized Quality of cognitive function, Higher values are better

Standardized Quality of sleep, Higher values are worse

The Myeloid Neoplasms Biology and Outcome Project

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status