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NCT Number: NCT06649253

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

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.

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Key information

Conditions

Leukemia, Lymphoblastic, Acute, Pediatric Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sampling bone tissue and blood

Other

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 outcomes

  1. Non coding RNA network in CD9 regulation

    Time frame: 5 years

    description 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 outcomes

  1. Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up

    Time frame: 5 years

    Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a follow-up marker in CD9+ pediatric B-ALL.

  2. Non coding RNA network in CD9 regulation as a predictive factor of relapse

    Time frame: 5 years

    Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a predictive marker of relapse in CD9+ pediatric B-ALL.

Study contacts

Contact information is provided by the study sponsor or research team.

Elie COUSIN, Md

CONTACT

[email protected]

299284321 ext. +33

marie-laure gervais, phd

CONTACT

[email protected]

299284321 ext. +33

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: REALL CD9

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Oct 18, 2024
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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