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Trial Title:
Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias
NCT ID:
NCT05729178
Condition:
Childhood Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
observational study
Description:
analysis of biomarkers of interest (DNA-RNA and proteins) in MNC purified from the
subjects' blood
Arm group label:
Pediatric acute lymphoblastic leukemia patients
Arm group label:
healthy subjects
Summary:
A transcriptomic analysis of bone marrow from B-ALL patients was performed by our
research group for identifying novel protein/factor with a putative role of disease
biomarker. Along with some already known B-ALL biomarkers, our analysis highlighted
deregulation of some members of an emerging protein class denoted as KCTD (Potassium
ChannelTetramerization Domain-containing proteins). Starting from our preliminary
observations, and considering that KCTDs havenever been studied in ALL, we decided to
study these proteins in B- and T-ALL affected pediatric patients, enrolled by our
research group in collaboration with AORN Santobono-Pausilipon pediatric oncological
hospital.Indeed, the present research program aims at opening a new scenario for the
study of KCTD proteins in childhood leukemias. The final goal of the project will be to
evaluate the translational relevance of selected deregulated KCTDs as novel biomarkers
useful for B-ALL and T-ALL diagnostics, and patient management.
Criteria for eligibility:
Study pop:
The study foresees the possibility of recruiting approximately 60 patients with B-ALL and
15-20 patients with T-ALL. Furthermore, control subjects with age and sex comparable to
those of the patients will be recruited. Finally, about 100 units of cord blood that do
not meet the criteria for therapeutic cryopreservation and for which consent has been
given for their use for scientific research will be used
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients aged 1-18 years of both sexes diagnosed with B- ALL and T-ALL;
- Patients who will have signed the informed consent
Exclusion Criteria:
- Patients who refuse to participate in the study;
- Patients who do not fall within the age range mentioned above
Gender:
All
Minimum age:
1 Year
Maximum age:
18 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IRCCS Synlab SDN
Address:
City:
Naples
Zip:
80143
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura Pierri, MSC
Phone:
0812408470
Email:
direzionescientifica.irccssdn@synlab.it
Start date:
March 2, 2020
Completion date:
July 31, 2025
Lead sponsor:
Agency:
IRCCS SYNLAB SDN
Agency class:
Other
Collaborator:
Agency:
Santobono-Pausilipon Hospital
Agency class:
Other
Source:
IRCCS SYNLAB SDN
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05729178
