Study of Dendrogenin A / Oxysterols Balance Between Healthy Volunteers and Acute Myeloid Leukemia Patients
NCT ID: NCT02602587
Last Updated: 2019-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
37 participants
INTERVENTIONAL
2014-11-25
2018-11-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Creation of a Biocollection of Patients with Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelodysplastic Syndrome (MDS) Monitored At the Nantes University Hospital
NCT06681363
Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms - The Biology and Outcome (BiO)-Project
NCT01252485
Role of PTK-7 in Acute Myeloid Leukemias
NCT02860793
Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
NCT02320656
Timed-Sequential Induction in CBF-AML
NCT00428558
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Purpose : This is a biomedical study of interventional type which includes 30 patients and 30 blood samples as well as 5 marrow samples from healthy donors. It will last 24 month, 8 months recruiting and 16 months follow-up. Patients with acute myeloid leukemia for which an indication of chemotherapy treatment is retained will be enrolled in this study. This study will compare oxysterols (Dendrogenin A, 6-oxo-cholestane-3beta,5alpha-diol - OCDO) and related proteins as biomarkers of the disease between the two populations.
Interventions : The patients included in this study will be processed according to the standard treatment in force for their disease. This study does not in any way interfere with this treatment regimen, and is only based on additional samples of blood and bone marrow in acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15 days following inclusion and first sampling.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
blood samples and bone marrow samples
The patients included in this study will be processed according to the standard treatment in force for their disease. This study does not in any way interfere with this treatment regimen, and is only based on additional samples of blood and bone marrow in acts planned in the prognostic or follow-up protocols. Treatment shall start within the 15 days following inclusion and first sampling.
Blood sample
additional samples of blood in acts planned in the prognostic or follow-up protocols.
Bone marrow sample
additional bone marrow sample in acts planned in the prognostic or follow-up protocols.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood sample
additional samples of blood in acts planned in the prognostic or follow-up protocols.
Bone marrow sample
additional bone marrow sample in acts planned in the prognostic or follow-up protocols.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Informed consent obtained and signed before any specific procedure in the study
* Patient member in a national insurance scheme
\* For patients with AML
* Men or women with a non promyelocytic acute myeloid leukemia as defined by WHO criteria and with at least 20% leukemic cells in blood at diagnosis
* for which treatment combining cytarabine and daunorubicin or idarubicin is retained
* WHO performance status ≤ 2
* for healthy volunteers Criteria of eligibility for blood or bone marrow donation according to French Blood Institution
Exclusion Criteria
* Patients under legal guardianship.
* Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
* Patient unable to follow procedures, visits, examinations described in the study.
\* For patients with AML :
* Patients having received any anti-AML treatment with the exception of oral hydroxyurea.
* Patients for which a treatment different from the combination cytarabine+anthracycline has been selected
\* For healthy volunteers
* Criteria of ineligibility for blood donation according to EFS (French Blood Institution)
* For bone marrow : heart disease, high blood pressure, respiratory diseases, diseases of the nervous system history of cancers, diseases metabolic (diabetes, liver failure), history of recurring phlebitis or pulmonary embolism, disabling lumbar problems, neuromuscular diseases, angioedema, significant overweight,.
* Any long term treatment, except contraception
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Toulouse
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christian RECHER, Doctor
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chu Toulouse
Toulouse, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
14 7166 03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.