Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project (AMLSG BiO)
This study is currently recruiting participants.
Verified February 2013 by University of Ulm
Sponsor:
University of Ulm
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT01252485
First received: December 2, 2010
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
This is a registry study in adult patients with newly diagnosed AML
Investigator's sites: 50-60 sites in Germany and Austria
Estimated duration of observation of an individual patient:
10 years maximum
Objectives
- To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)
- To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
- To assess 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 (eg, bone marrow, blood, plasma, buccal swap, sputum, skin biopsy samples)
- To assess quality of life
| Condition |
|---|
|
Acute Myeloid Leukemia (AML) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Registry Study on Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Acute Leukemias of Ambiguous Lineage - The AMLSG Biology and Outcome (BiO)-Project |
Resource links provided by NLM:
Further study details as provided by University of Ulm:
Primary Outcome Measures:
- Completeness [ Designated as safety issue: No ]To register all patients with newly diagnosed AML in all AMLSG participating centers (completeness)
- incidence of relevant genetic markers [ Designated as safety issue: No ]To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
- Event-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) [ Designated as safety issue: No ]To perform timely analyses of relevant genetic markers (according to WHO 2008 classification) (incidences, treatment decision)
- quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
| Study Start Date: | July 2010 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with newly diagnosed AML in all AMLSG participating centers (50-60 centers in Germany and Austria)
Criteria
Inclusion Criteria:
- Patients with suspected diagnosis of acute myeloid leukemia or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) classification)
- Age ≥ 18 years. There is no upper age limit.
- No prior chemotherapy* for leukemia except hydroxyurea to control hyperleukocytosis
- Signed written informed consent *prior therapy of a preceding myelodysplastic syndrome or myeloproliferative neoplasm is allowed
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 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252485
Contacts
| Contact: Richard F Schlenk, MD | 49-731-500-45900 | richard.schlenk@uniklinik-ulm.de |
Locations
| Germany | |
| University Hospital of Ulm | Recruiting |
| Ulm, Germany, 89081 | |
| Contact: Richard F Schlenk, MD 49-731-500-45900 richard.schlenk@uniklinik-ulm.de | |
Sponsors and Collaborators
University of Ulm
Investigators
| Study Chair: | Richard F Schlenk, MD | University Hospital of Ulm |
More Information
No publications provided
| Responsible Party: | Dr. Richard Schlenk, PD Dr., University of Ulm |
| ClinicalTrials.gov Identifier: | NCT01252485 History of Changes |
| Other Study ID Numbers: | AMLSG BiO |
| Study First Received: | December 2, 2010 |
| Last Updated: | February 26, 2013 |
| Health Authority: | Germany: Registry Study -> no responsible oversight authority |
Keywords provided by University of Ulm:
|
AML Registry study Biology and Outcome |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013