Skip to main content
Clinical Trials/NCT03125707
NCT03125707RecruitingNot Applicable

German MPN-Registry for BCR-ABL 1-Negative Myeloid Neoplasms (Study Group Ulm)

University of Ulm30 sites in 1 country2,172 target enrollmentStarted: May 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
2,172
Locations
30
Primary Endpoint
Overall survival

Study Overview

Brief Summary

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers

To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)

To perform morphologic and genetic analyses

To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables

To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)

To assess quality of life

Detailed Description

To register a large number of patients with the diagnosis of a BCR-ABL 1- negative myeloid neoplasm (according to WHO 2008 / 2016 classification) in participating centers

To store samples from all patients (e.g. bone marrow aspirate, peripheral blood, plasma, and buccal swap, skin biopsy samples in exceptional cases)

To perform morphologic and genetic analyses

To assess clinical characteristics and outcome data using a defined catalogue containing clinically relevant variables

To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Both female and male patients meeting the mentioned inclusion criteria will be included in this registry, because the risk to get a myeloid neoplasm does not depend on a patient's gender. Patients must meet all of the following inclusion criteria to be eligible for enrollment into the registry:
  • Patients with BCR-ABL 1-myeloid neoplasia according to WHO classification or IWG MRI criteria
  • Age ≥ 18 years. There is no upper age limit.
  • Signed written informed consent.

Exclusion Criteria

  • Severe neurological or psychiatric disorder interfering with ability to give an informed consent
  • No consent for registration, storage and handling of the personal data

Outcomes

Primary Outcomes

Overall survival

Time Frame: 25 years

Survival over the whole study duration

Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.

Time Frame: 25 years

Quality of life assessed by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF Protocol 5/25/11, EORTC QLQ-C30, FACT-Lym (Fassung 4)), supplemented by information on self-assessed concomitant diseases and demographics.

Treatment decision

Time Frame: 25 years

Treatment decision (watch and wait, standard, investigational)

Response

Time Frame: 25 years

Response of treatment

Duration of response

Time Frame: 25 years

Duration of response over the whole study duration

Progression-free-survival

Time Frame: 25 years

Survival without any progression

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Ulm
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Frank Stegelmann

Principal Investigator Dr. med.

University of Ulm

Study Sites (30)

Loading locations...

Similar Trials