Epidemiologic Registry PETHEMA LMA 2013

AML Clinical Trial

Official title:

Epidemiologic Registry of Patients Diagnosed With Acute Myeloid Leukemia (PETHEMA LMA 2013)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02006004
• Other study ID #: PETHEMA LMA 2013
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: October 13, 2015
• Start date: January 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: PETHEMA Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Epidemiologic and retrospective multicenter registry of all patients diagnosed with de novo or secondary AML in the PETHEMA Group institutions. This study is a non-interventional research regarding diagnosis and therapeutic approach

Description:

To perform this registry, every patient diagnosed with AML in the participant institutions, regardless type of AML and treatment administered, must be reported. It will be required to registry the main characteristics of the patients and AML at diagnosis, as cytomorphologic, immunophenotypic, and cytogenetic results, according to the habitual practice of the centers. The treatment which has been administered by every center of the PETHEMA Group, even when it is considered as supportive care, and evolution of the disease will also be reported (relapse o death). PETHEMA Group will input all the reported information in data bases with the appropriate security.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients diagnosed with acute myeloid leukemia

Exclusion Criteria:

no exclusion criteria

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• AML

Locations

Country	Name	City	State
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
PETHEMA Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of the patients diagnosed with AML	To realize an epidemiologic and retrospective study to assess the characteristics of the patients diagnosed with AML and their disease, regardless the age or treatment	3 years	No
Secondary	Prognosis factors	To correlate clinical and biological features with outcome and evolution of the patients.	3 years	No
Secondary	Risk factors	To identify and confirm the risk factors which are involved in the evolution of the disease.	3 years	No