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Dependence Receptors and Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278145
Recruitment Status : Unknown
Verified September 2017 by Hospices Civils de Lyon.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

Acute leukaemias (AL) are the first cause of cancer in children, with a majority of B acute lymphoblastic leukemia (ALL). Some of the processes causing leukemogenesis are already identified and well characterized in some AL subtypes such as translocation t (12; 21) of good prognosis in ALL. However, translocations are not sufficient to explain all the different processes of leukemogenesis, and other processes such as genetic / epigenetic mutations leading to oncogene activation / inhibition of tumor suppressor genes are the object research. Among the latter, mutations in tumor suppressor genes such as DCC (Deleted in Colorectal Cancer) have recently been identified in solid cancers, such as in hemopathies. This gene was subsequently characterized as encoding a "dependence receptor" specifically binding to its Netrin-1 ligand.

Dependence receptors (RDs) are transmembrane receptors that cause cell death in the absence of their ligand. RD decreases tumor progression and overexpression of their ligands is observed in many cancers, such as B lymphomatous hemopathies in adults. Inhibition of the RD-ligand interaction constitutes a new and original therapeutic target in oncology.

The aim of this study is to investigate whether RDs, in particular DCC, are expressed in acute leukemia cells at the time of diagnosis or relapse in patients aged 1 to 18 years, and then in these patients at the time of the remission balance. This research will be both qualitative and quantitative.


Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Acute Leukemia Genetic: Genetic analyses

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dependence Receptors in Childhood Acute Leukemia
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019


Group/Cohort Intervention/treatment
Pediatric acute leukemia
Patients of the Institute of Hematology and Pediatric Oncology (IHOPe) with acute leukemia (LA) who came for initial diagnosis, relapse, or at the time of their remission .
Genetic: Genetic analyses
Patients treated at the Institute of Hematology and Pediatric Oncology (IHOPe), a department of Prof. Y. Bertrand, for acute leukemia (LA) at the time of diagnosis initial, or relapse, after obtaining signed parental consent. The same patients will benefit from a new sample at the time of their remission balance. Analyses for this research will be made from bone marrow aspiration samples performed for diagnosis and treatment of these patients. The medical team will investigate whether RDs, in particular DCC, are expressed in acute leukemia cells at the time of diagnosis or relapse and then in these patients at the time of the remission balance. This research will be both qualitative and quantitative. Next, investigators will characterize the existence and then the level of expression of the ligand specific for DCC, Netrin-1, in these same leukemic cells, at the time of diagnosis / relapse and remission.




Primary Outcome Measures :
  1. Detection of specific labeling of the DCC-dependent receptor on the surface of leukemic cells [ Time Frame: Maximum 4 months (sampling at the time of diagnosis / relapse and remission) ]

    Primary endpoint: presence of specific labeling of the DCC-dependent receptor on the surface of leukemic cells that will be detectable in flow cytometry.

    This marking will be both qualitative (positive signal = presence of the receptor, absence of signal = absence of the receptor), and quantitative (percentage of expression of the receptor on the surface of the cells).



Biospecimen Retention:   Samples With DNA
Bone marrow aspiration sample


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The target population consists of patients aged 1 to 18 years treated at the Institute of Hematology and Pediatric Oncology (IHOPe), a department of Prof. Y. Bertrand, for acute leukemia (LA) at the time of diagnosis initial, or relapse, after obtaining signed parental consent. The same patients will benefit from a new sample at the time of their remission balance.
Criteria

Inclusion Criteria:

  • aged between 1 and 18 years
  • taken care of at the Institute of Hematology and Pediatric Oncology (Service of Professor Yves Bertrand, IHOPe)
  • for acute lymphoblastic or myeloblastic leukemia
  • initial diagnosis or relapse
  • who do not have a vital emergency criterion at the time of taking care (see exclusion criteria)
  • affiliated to a social security scheme (100% assumed)
  • after signing the informed consent of the holders of parental authority

Exclusion Criteria:

  • less than 1 year, or more than 18 years to diagnosis
  • with chronic leukemia
  • severe anemia at diagnosis (hemoglobin <40g / l), or a state of shock whatever the cause (infectious, cardiogenic, hypovolemic)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278145


Contacts
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Contact: Carine HALFON-DOMENECH, M.D, PhD 04 69 16 65 67 ext +33 carine.halfon-domenech@chu-lyon.fr
Contact: Patrick MEHLEN, MD 04-78-78-28-70 ext +33 patrick.mehlen@lyon.unicancer.fr

Locations
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France
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69008
Contact: Carine HALFON-DOMENECH, M.D, PhD    04 69 16 65 67 ext +33    carine.halfon-domenech@chu-lyon.fr   
Contact: Patrick MEHLEN, MD    04-78-78-28-70    patrick.mehlen@lyon.unicancer.fr   
Principal Investigator: Carine HALFON-DOMENECH, M.D, PhD         
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03278145    
Other Study ID Numbers: 69HCL16_0806
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases