The Myeloid Neoplasms Biology and Outcome Project

NCT05074316 | Recruiting DMC

• 1 other identifier: MyBOP
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Direct access to new and personalized treatment approaches through recruitment into clinical studies based on the myeloid neoplasms study platform
3. 3.Quality assurance of participating centers by evaluating and comparing clinical outcomes and side effects of the MyBOP patients with published data.

Conditions

Myeloid Neoplasm

Keywords

outcome project; registry

Outcome Measures

Primary Outcomes (4)

• median overall survival (mOS)

  Time period of survival from date of diagnosis of myeloid neoplasy

  5 years

• overall survival (mOS)

  Time period of survival from date of diagnosis of myeloid neoplasy

  10 years

• event free survival (EFS)

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

  5 years

• progression free survival (PFS)

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

  5 years

Secondary Outcomes (5)

• Questionnaire for the health- related quality of life QLQ-C30

  5 years

• Questionnaire for physical, cognitive and emotional aspects of cancer-related fatigue QLQ-FA12

  5 years

• Questionnaire for anxiety and depression PHQ-4

  5 years

• Functional Assessment of Cancer Therapy Fact-Cog

  5 years

• The Pittsburgh Sleep Quality Index PSQI

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patient cohort will be selected from the University Hospital Heidelberg.

You may qualify if:

• Suspected or proven diagnosis of Myeloid Neoplasms according to the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues
• Age ≥18 years
• Ability to understand the nature and individual consequences of the registry
• Written informed consent
• Subjects who are physically or mentally capable of giving consent

You may not qualify if:

• Severe neurological or psychiatric disorder interfering with the ability to give written informed consent

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

UHHeidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Biospecimen

Retention: NONE RETAINED

clinically and molecularly annotated biospecimens are collected and stored within the biobank structures of the Department of Internal Medicine V of the Heidelberg University Hospital including blood and bone marrow samples, plasma and serum including liquid biopsies (cfDNA).

Study Officials

• Richard F Schlenk, M.D.

  University Hospital Heidelberg, Department of Internal Medicine V, German Cancer Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Editha Gnutzmann, M.A.

CONTACT

+49 6221 56 36235; editha.gnutzmann@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of NCT trials center and Clinical Trials Office Hematology/Oncology

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 12, 2021
• Study Start: March 10, 2020
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

DE (1)