Childhood B-acute Lymphoblastic Leukaemia and Role of CD9 Gene Regulation in Relapse

Official title

REALL CD9 : Molecular Mechanisms Involved in Relapses of Childhood B-acute Lymphoblastic Leukaemia, Role of Non-coding RNA in CD9 Gene Regulation

Overview

B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing. CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells and could be associated with relapses. The aim of this project is to understand how CD9 regulation can be a marker of potential relapses, using bone and blood sampling of newly diagnosed patients at 3 crucial moments of therapy.

Detailed description

B-acute lymphoblastic leukaemia (B-ALL) is the most common cancer in children, with 20% of patients relapsing despite major therapeutic advances. A research team of the Development and Genetic Institute in Rennes has identified that the expression of CD9, a transmembrane protein, is linked to the migratory and adhesion capacities of leukaemia cells, enabling them to persist in niches such as the testis. CD9-associated relapses often arise from these niches. Understanding the regulation of CD9 expression is therefore essential.

The hypothesis on which this project is based is that CD9 expression could be orchestrated by ncRNAs. Due to the complexity of deciphering circRNA-miRNA-mRNA networks, an exploration of patient blasts is envisaged in order to delineate a specific non-coding RNA network regulating CD9 expression from bone marrow and blood samples of paediatric-aged patients with B-ALL. If this hypothesis is confirmed, the ncRNAs identified could constitute new specific diagnostic and prognostic markers, or even therapeutic targets.

To confirm this hypothesis, bone and blood sampling of newly diagnosed patients will be collected at the diagnosis, after first phase of treatment and at the relapse, if it occurs.

Interventions

• Other Sampling bone tissue and blood
  Extra tube collection of bone and blood will be collected during routine care sampling interventions at the diagnosis, after the first phase of treatment and after relapse, if it occurs.

Primary outcome measures

• Non coding RNA network in CD9 regulation [Time frame: 5 years]

Secondary outcome measures (2)

• Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up [Time frame: 5 years]
• Non coding RNA network in CD9 regulation as a predictive factor of relapse [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

• Under 18 years
• With established diagnosis of B-ALL
• Initial diagnosis made in the investigating centre
• Having received oral and written information about the protocol, or oral only if the patient is unable to read.
• Having signed a consent form if the patient is capable of giving informed written consent.
• Whose legal guardians have received oral and written information about the protocol, and have signed a free, informed and written consent.
• Beneficiary of a social security scheme

Exclusion criteria

• Isolated extramedullary involvement at inclusion
• Patient of childbearing age without effective contraception.
• Adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

France · 3 centers

• CHU Angers — Angers
• CHU Brest — Brest
• CHU Rennes — Rennes

Identifiers

NCT: NCT06649253 · 35RC23_8885_REALLCD9

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗