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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06649253
Acronym
REALL CD9
Enrollment
50
Registered
2024-10-18
Start date
2025-03-22
Completion date
2035-04-30
Last updated
2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoblastic, Acute, Pediatric

Keywords

CD9, miRNA, gene regulation

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.

Interventions

OTHERSampling 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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Non coding RNA network in CD9 regulation5 yearsdescription of the network of lncRNAs (circRNAs/miRNAs) involved in the regulation of CD9 present on the surface of blasts at the time of diagnosis of B-ALL (nature of the lncRNAs, level of expression, etc.)

Secondary

MeasureTime frameDescription
Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up5 yearsActivity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a follow-up marker in CD9+ pediatric B-ALL.
Non coding RNA network in CD9 regulation as a predictive factor of relapse5 yearsActivity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a predictive marker of relapse in CD9+ pediatric B-ALL.

Countries

France

Contacts

Primary ContactElie COUSIN, Md
elie.cousin@univ-rennes.fr299284321
Backup Contactmarie-laure gervais, phd
marie-laure.gervais@chu-rennes.fr299284321

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026