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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

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