Ignite Creation Date:
2024-05-05 @ 11:06 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01252485
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2010-12-02
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
Sponsor:
University of Ulm
Organization:
University of Ulm
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMLSG BiO
Brief Summary:
This is a registry study in adult patients with newly diagnosed or refractoryrelapsed myeloid neoplasms
Investigators 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 relapsedrefractory 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 eg bone marrow blood plasma normal tissue eg skin biopsy buccal swap finger nails hairs or sputum
To assess quality of life
Investigators 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 relapsedrefractory 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 eg bone marrow blood plasma normal tissue eg skin biopsy buccal swap finger nails hairs or sputum
To assess quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None