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Trial Title:
Childhood B-acute Lymphoblastic Leukaemia and Role of CD9 Gene Regulation in Relapse
NCT ID:
NCT06649253
Condition:
Leukemia, Lymphoblastic, Acute, Pediatric
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Conditions: Keywords:
CD9
miRNA
gene regulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Sampling bone tissue and blood
Description:
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.
Arm group label:
Patients
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
0 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU Angers
Address:
City:
Angers
Country:
France
Contact:
Last name:
Isabelle PELLIER, pr
Phone:
241353637
Phone ext:
+33
Email:
ispellier@chu-angers.fr
Contact backup:
Last name:
Isabelle PELLIER, Pr
Facility:
Name:
CHU Brest
Address:
City:
Brest
Country:
France
Contact:
Last name:
Liana CARAUSU, Pr
Phone:
298223333
Phone ext:
+33
Email:
liana.carausu@chu-brest.fr
Contact backup:
Last name:
Liana CARAUSU, pr
Facility:
Name:
CHU Rennes
Address:
City:
Rennes
Country:
France
Contact:
Last name:
Virginie GANDEMER, Pr
Phone:
29928254321
Phone ext:
+33
Email:
virginie.gandemer@chu-rennes.fr
Contact backup:
Last name:
Virginie GANDEMER, Pr
Start date:
November 2024
Completion date:
June 2035
Lead sponsor:
Agency:
Rennes University Hospital
Agency class:
Other
Source:
Rennes University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06649253
