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

NCT ID: NCT06649253

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-22

Study Completion Date

2035-04-30

Brief Summary

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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

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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.

Conditions

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Leukemia, Lymphoblastic, Acute, Pediatric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients

All included patients. Bone and blood sampling

Group Type EXPERIMENTAL

Sampling bone tissue and blood

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elie COUSIN

Role: STUDY_CHAIR

Rennes University

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

CHU Brest

Brest, , France

Site Status RECRUITING

CHU Rennes

Rennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Elie COUSIN, Md

Role: CONTACT

299284321 ext. +33

marie-laure gervais, phd

Role: CONTACT

299284321 ext. +33

Facility Contacts

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Isabelle PELLIER, pr

Role: primary

241353637 ext. +33

Liana CARAUSU, Pr

Role: primary

298223333 ext. +33

Virginie GANDEMER, Pr

Role: primary

29928254321 ext. +33

Other Identifiers

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35RC23_8885_REALLCD9

Identifier Type: -

Identifier Source: org_study_id

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