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Clinical Trials/NCT03278145
NCT03278145UnknownNot Applicable

Dependence Receptors in Childhood Acute Leukemia

Hospices Civils de Lyon1 site in 1 country30 target enrollmentStarted: November 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
1
Primary Endpoint
Detection of specific labeling of the DCC-dependent receptor on the surface of leukemic cells

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
1 Year to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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