NCT02602587

Brief Summary

Dendrogenin A is present in mammals normal tissues and fluids, notably blood. It is down-represented or absent in cancer cell lines and tumors. In the opposite, OCDO is accumulated in cancerous conditions and virtually absent of normal tissues. This study will try to determine modulations of these oxysterols and protein involved in their metabolism between Acute myeloid leukemia (AML) patient samples and normal blood or marrow, for evaluation of these markers as companion biomarkers for Dendrogenin A treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2018

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

November 2, 2015

Last Update Submit

May 10, 2019

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemiaDendrogenin A5,6-cholesterol epoxide6-oxo-cholestane-3beta5alpha-diolcholesterol epoxide hydrolaseoxysterols

Outcome Measures

Primary Outcomes (1)

  • Difference of dendrogenin A between patients and healthy donors

    Comparison of levels of Dendrogenin A, oxysterols and related proteins between healthy volunteers and AML patients

    day 1

Secondary Outcomes (1)

  • 50 percent inhibitory concentration

    day 1

Study Arms (1)

blood samples and bone marrow samples

EXPERIMENTAL

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.

Biological: Blood sampleBiological: Bone marrow sample

Interventions

Blood sampleBIOLOGICAL

additional samples of blood in acts planned in the prognostic or follow-up protocols.

blood samples and bone marrow samples
Bone marrow sampleBIOLOGICAL

additional bone marrow sample in acts planned in the prognostic or follow-up protocols.

blood samples and bone marrow samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women of 18 years old or older
  • 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

You may not qualify if:

  • Pregnant women or nursing mothers cannot participate in the study.
  • Patients under legal guardianship.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christian RECHER, Doctor

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 11, 2015

Study Start

November 25, 2014

Primary Completion

November 20, 2018

Study Completion

November 20, 2018

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations

FR(1)