Clinical trial NCT06649253: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia, Lymphoblastic, Acute, Pediatric
Keywords: CD9
miRNA
gene regulation
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Non coding RNA network in CD9 regulation
timeFrame: 5 years
Secondary outcomes:
measure: Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up
timeFrame: 5 years
measure: Non coding RNA network in CD9 regulation as a predictive factor of relapse
timeFrame: 5 years
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: Rennes University
name: Elie COUSIN
role: STUDY_CHAIR
References: