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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Leukemia, Lymphoblastic, Acute, Pediatric
• Intervention / Treatment: Other: Sampling bone tissue and blood

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elie COUSIN, Md; Phone Number: +33 299284321; Email: elie.cousin@univ-rennes.fr
• Study Contact Backup: Name: marie-laure gervais, phd; Phone Number: +33 299284321; Email: marie-laure.gervais@chu-rennes.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • CHU Angers
    • Principal Investigator: Isabelle PELLIER, Pr
    • Contact: Isabelle PELLIER, pr; Phone Number: +33 241353637; Email: ispellier@chu-angers.fr
  • Brest, France
    • Recruiting
    • CHU Brest
    • Contact: Liana CARAUSU, Pr; Phone Number: +33 298223333; Email: liana.carausu@chu-brest.fr
    • Principal Investigator: Liana CARAUSU, pr
  • Rennes, France
    • Recruiting
    • Chu Rennes
    • Contact: Virginie GANDEMER, Pr; Phone Number: +33 29928254321; Email: virginie.gandemer@chu-rennes.fr
    • Principal Investigator: Virginie GANDEMER, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; All included patients. Bone and blood sampling	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non coding RNA network in CD9 regulation	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.)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non coding RNA network in CD9 regulation as a prognosis factor of disease follow-up	Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a follow-up marker in CD9+ pediatric B-ALL.	5 years
Non coding RNA network in CD9 regulation as a predictive factor of relapse	Activity of the ncRNA (circRNA/miRNA) network regulating CD9 gene expression as a predictive marker of relapse in CD9+ pediatric B-ALL.	5 years

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Chair: Elie COUSIN, Rennes University

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2025
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 17, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: miRNA; CD9; gene regulation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 35RC23_8885_REALLCD9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No