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

NCT06649253 | Recruiting

• 1 other identifier: 35RC23_8885_REALLCD9
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Leukemia, Lymphoblastic, Acute, Pediatric

Keywords

CD9; miRNA; gene regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  5 years

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

  5 years

Study Arms (1)

Patients

EXPERIMENTAL

All included patients. Bone and blood sampling

Other: Sampling bone tissue and blood

Interventions

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.

Patients

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patient of childbearing age without effective contraception.
• Adult subject to legal protection (safeguard of justice, curatorship, guardianship), person deprived of liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (3)

CHU Angers

Angers, France

RECRUITING

CHU Brest

Brest, France

RECRUITING

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Leukemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Elie COUSIN

  Rennes University

  STUDY CHAIR

Central Study Contacts

Elie COUSIN, Md

CONTACT

299284321; elie.cousin@univ-rennes.fr

marie-laure gervais, phd

CONTACT

299284321; marie-laure.gervais@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: March 22, 2025
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (3)