Metabolism Des LAM | NCT02176109

Studies
Metabolism Des LAM

NCT02176109

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Jun 26, 2014Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Iron
Acute Myeloid Leukemia
Diagnosis
Oxydative Stress

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Métabolismes des LAM	Registry Identifier	2013-A00762-43

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2018Estimated

First Submitted Date

Jun 24, 2014

First Submission Date that Met QC Criteria

Jun 25, 2014

First Posted Date

Jun 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 25, 2014

Last Update Posted Date

Jun 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.

Detailed Description

Primary goal of this study is to Evaluate the characteristics of regulatory networks of iron and redox balance in leukemic cells, to study the correlations between the prognosis of AML patients (in terms of response to induction chemotherapy and survival i) and metabolism of these markers. Secondary ones areto assess the impact of induction therapy on markers of oxidative stress and to correlate biological iron and redox metabolism with the molecular status of patients (eg Flt3/IDH/CEBPA/NPM...).

Eligibility criteria are patients at diagnostic of de novo acute myeloid leukemia (promyelocytic excluded) aged from 18 to 100 years.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

80Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival		five years after the inclusion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis

Exclusion Criteria:

age under 18 years promelocytic leukemia secondary leukemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

de novo acute myeloid leukemic patient from 18 years to 99 years. promyelocytic leukemia excluded

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
pascal mossuz, phd	Contact			pmossuz@chu-grenoble.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Grenoble	Recruiting	Grenoble	Isere	38043	France

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D004194	Disease

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided