Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project (AMLSG BiO)

• ClinicalTrials.gov Identifier: NCT01252485
• Recruitment Status: Recruiting
• First Posted: December 3, 2010
• Last Update Posted: May 8, 2024
• Sponsor: University of Ulm
• Information provided by (Responsible Party): Prof. Dr. Hartmut Doehner, University of Ulm

Tracking Information

• First Submitted Date: December 2, 2010
• First Posted Date: December 3, 2010
• Last Update Posted Date: May 8, 2024
• Study Start Date: July 2010
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: September 9, 2016)

• incidence of disease-related genetic markers [ Time Frame: 4 weeks ]
  To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
• Event-free survival [ Time Frame: 10 years ]
  To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Cumulative incidence of relapse [ Time Frame: 10 years ]
  To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Cumulative incidence of death [ Time Frame: 10 years ]
  To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Overall survival [ Time Frame: 10 years ]
  To assess patient and family history, patient characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Treatment decision (intensive, non-intensive, investigational) [ Time Frame: 1 year ]
  To perform timely analyses of disease-related genetic markers (according to WHO 2008 classification) (incidences, treatment recommendations)
• quality of life [ Time Frame: 5 years ]
  Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, socioeconomics, and demographics according to Messerer D et al (2008) initially, in first CR, one year, 3 and 5 years after initial diagnosis.
• Geographical representation [ Time Frame: 1 day ]
  Geographical representation of patients through collection of patients zip codes

Original Primary Outcome Measures (submitted: December 2, 2010)

• Completeness
  To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)
• incidence of relevant genetic markers
  To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
• Event-free survival [ Time Frame: 10 years ]
  To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Cumulative incidence of relapse [ Time Frame: 10 years ]
  To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Cumulative incidence of death [ Time Frame: 10 years ]
  To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Overall survival [ Time Frame: 10 years ]
  To assess clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• Treatment decision (intensive, non-intensive, investigational)
  To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
• quality of life [ Time Frame: 5 years ]
  Quality of life assessed by the EORTC Quality of Life Core Questionnaire (QLQ-C30), supplemented by information on self-assessed concomitant diseases, late treatment effects, and demographics according to Messerer et al [40] initially, in first CR, one year, 3 and 5 years after initial diagnosis.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project
• Official Title: Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome - The Biology and Outcome (BiO)-Project

Brief Summary

This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms

Investigator's sites: 60-70 sites in Germany and Austria

Estimated duration of observation of an individual patient:

10 years maximum

Objectives

• To register all patients with acute myeloid leukemia and related precursor neoplasms, acute leukemia of unambiguous lineage, with higher risk myelodysplastic syndromes (MDS with excess blasts 2), and with myeloid neoplasms with germline predisposition, newly diagnosed or relapsed/refractory in all participating centers (completeness)
• To perform timely analyses of disease-related genetic markers (incidences, treatment recommendations)
• To assess patient and family history, clinical characteristics and outcome data (event-free survival [EFS], cumulative incidence of relapse [CIR], cumulative incidence of death [CID], overall survival [OS])
• To assess biological disease features and correlate with clinical outcome data (prognostic and predictive markers)
• To store biosamples from all patients (e.g., bone marrow, blood, plasma, normal tissue, e.g., skin biopsy, buccal swap, finger nails, hairs, or sputum)
• To assess quality of life

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: patients with newly diagnosed or relapsed/refractory AML in all AMLSG participating centers (60-70 centers in Germany and Austria)

Condition

• Acute Myeloid Leukemia (AML)
• Higher Risk Myelodysplastic Syndromes (MDS With Excess Blasts 2)

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Patients with suspected diagnosis of AML and related precursor neoplasms, acute leukemias of ambiguous lineages, higher risk MDS (MDS with excess blasts 2 [MDS-EB2]), and myeloid neoplasm with germline predisposition, newly diagnosed or relapsed/refractory, classified according to the World Health Organization (WHO) classification
• 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 processing of the individual patient and disease characteristics and course as well as information of the family physician about study participation
• No consent for biobanking of patient's biological specimens and performance of analyses on stored material.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Hartmut Döhner, Prof. Dr.; 49-731-500-45501; hartmut.doehner@uniklinik-ulm.de

• Listed Location Countries: Germany, Austria

Administrative Information

• NCT Number: NCT01252485
• Other Study ID Numbers: AMLSG BiO
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Prof. Dr. Hartmut Doehner, University of Ulm
• Original Responsible Party: Richard F. Schlenk, University of Ulm
• Current Study Sponsor: University of Ulm
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Hartmut Döhner, Prof. Dr.; University Hospital of Ulm

• PRS Account: University of Ulm
• Verification Date: May 2024