NCT01252485 Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
| NCT ID | NCT01252485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ulm |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50,000 participants |
| Start Date | 2010-07-06 |
| Primary Completion | 2044-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50,000 participants in total. It began in 2010-07-06 with a primary completion date of 2044-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a registry study in adult patients with newly diagnosed or refractory/relapsed myeloid neoplasms Investigator's sites: 80-90 sites in Germany and Austria Estimated duration of observation of an individual patient: 10 years maximum Objectives * To register all patients with AML and related neoplasms, newly diagnosed or relapsed/refractory in all AMLSG participating centers (completeness) * To perform rapid analyses of disease-related genetic markers (incidences, treatment recommendations) * To assess patient and family history, as well as patient characteristics * To evaluate treatment response (CR, CRh, CRi) and outcome data (event-free survival \[EFS\], relapse-free survival \[RFS\], cumulative incidence of relapse \[CIR\], cumulative incidence of death \[CID\], overall survival \[OS\]) * To evaluate the impact of measurable residual disease (MRD) by different methods * 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, finger nails, hairs, sputum, or urine)
Eligibility Criteria
Inclusion Criteria: * Patients with suspected diagnosis of acute myeloid leukemia and related neoplasms, newly diagnosed or relapsed/refractory, classified according to the International Consensus 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.
Contact & Investigator
Hartmut Döhner, Prof. Dr.
STUDY CHAIR
University Hospital of Ulm
Frequently Asked Questions
Who can join the NCT01252485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01252485 currently recruiting?
Yes, NCT01252485 is actively recruiting participants. Contact the research team at hartmut.doehner@uniklinik-ulm.de for enrollment information.
Where is the NCT01252485 trial being conducted?
This trial is being conducted at Graz, Austria, Innsbruck, Austria, Linz, Austria, Linz, Austria and 11 additional locations.
Who is sponsoring the NCT01252485 clinical trial?
NCT01252485 is sponsored by University of Ulm. The principal investigator is Hartmut Döhner, Prof. Dr. at University Hospital of Ulm. The trial plans to enroll 50,000 participants.
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