Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias

NCT ID: NCT05729178

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2025-07-31

Brief 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.

Conditions

Childhood Acute Lymphoblastic Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric acute lymphoblastic leukemia patients

pediatric patients of 1-16 years old affected by acute lymphoblastic leukemia

observational study

Intervention Type: OTHER

analysis of biomarkers of interest (DNA-RNA and proteins) in MNC purified from the subjects' blood

healthy subjects

cord blood from healthy donors that cannot be used for clinical purposes

observational study

Intervention Type: OTHER

analysis of biomarkers of interest (DNA-RNA and proteins) in MNC purified from the subjects' blood

Interventions

observational study

analysis of biomarkers of interest (DNA-RNA and proteins) in MNC purified from the subjects' blood

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Santobono-Pausilipon Hospital

UNKNOWN

Sponsor Role: collaborator

IRCCS SYNLAB SDN

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Synlab SDN

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Laura Pierri, MSC

Role: CONTACT

direzionescientifica.irccssdn@synlab.it

0812408470

Facility Contacts

Laura Pierri, MSC

Role: primary

direzionescientifica.irccssdn@synlab.it

0812408470

Other Identifiers

5/19

Identifier Type: -

Identifier Source: org_study_id