IronLAM-ROSNCT02176109
Metabolism Des LAM
An observational study of Iron and Acute Myeloid Leukemia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron, Acute Myeloid Leukemia, Diagnosis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: de novo acute myeloid leukemic patient from 18 years to 99 years. promyelocytic leukemia excluded
Who may be able to join
- de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis
Who cannot join
- age under 18 years promelocytic leukemia secondary leukemia
Trial locations and contacts
1 site in 1 country.
pascal mossuz, phd contact
France1 site, 1 recruiting
- Recruiting
University Hospital Grenoble
Grenoble, Isere, 38043
pascal mossuz, phd, 0033476763220, pmossuz@chu-grenoble.fr
pascal mossuz, phd
About this study
Official title: Rôle Pronostique Des métabolismes du Stress Oxydatif et du Fer Dans Les Leucémies Aiguës Myéloblastiques
In this study, the investigators study the prognostic role of oxidative stress metabolism and iron in Acute myeloid leukemia.
Read the 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.
- Conditions
- Iron, Acute Myeloid Leukemia, Diagnosis, Oxydative Stress
- Medical subject headings
- Leukemia, Myeloid, Acute, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival
Measured: five years after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IronStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176109
- Sponsor's protocol ID
- gre-lam-fer
- Other IDs
- Métabolismes des LAM
- Acronym
- LAM-ROS
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle Pronostique Des métabolismes du Stress Oxydatif et du Fer Dans Les Leucémies Aiguës Myéloblastiques
- ClinicalTrials.gov ID
- NCT02176109
- Acronym / sponsor ID
- LAM-ROS / gre-lam-fer
- Conditions
- Iron, Acute Myeloid Leukemia, Diagnosis, Oxydative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 26 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- de novo acute myeloid leukemic patient from 18 years to 99 years. promyelocytic leukemia excluded
Key inclusion criteria (1 listed)
- de novo acute myeloid leukemic patient from 18 years to 99 years at diagnosis
Key exclusion criteria (1 listed)
- age under 18 years promelocytic leukemia secondary leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival
Time frame: five years after the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pascal mossuz, phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron and Acute Myeloid Leukemia, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact pascal mossuz, phd (pmossuz@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival Event-free survival Response to induction chemotherapy, overalll survival, event-free survival (time frame: five years after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.