Long Non-coding RNAs and Their Role on Epigenome as Diagnostic Markers in Childhood Acute Lymphoblastic Leukemia of T Cells.

NCT06334835 | Recruiting

• 1 other identifier: 1/23 OSS SDN
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Long non-coding RNAs (lncRNAs) are a class of biomarkers of crescent interest in the hematologic and oncologic field. They do not encode proteins and can alter gene expression by acting on different steps of regulation, including DNA methylation and chromatin structure. Recent data identified recurrent somatic alterations in genes involved in DNA methylation and post-translational histone modifications in T-ALL, suggesting that epigenetic homeostasis is critically required in restraining tumor development in the T-cell lineage. Further, recent studies showed that the expression levels of specific lncRNAs correlate with the prognosis of patients with Acute Lymphoblastic Leukemia of T-cells (T-ALL). The objectives of this research project are to identify T-ALL-specific lncRNAs to be used as new diagnostic and prognostic biomarkers of disease and to explore their role on chromatin reorganization and transcriptional regulation that may lead to the onset and progression of T-ALL.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

Lymphocytes; Lymphocyte function; Differentiation of B lymphocytes; Differentiation of T lymphocytes; ALL; CLL; MLL

Outcome Measures

Primary Outcomes (1)

• Evaluation of the expression of selected lncRNAs in pediatric T-ALL patients and cellular models of T-ALL

  Study of the expression of selected lncRNAs in pediatric T-ALL patients by RT-PCR. Profiling of chromatin accessibility and DNA methylation landscape in pediatric T-ALL patients in comparison with the healthy subjects, through ATAC-seq and MethylC-seq experiments.

  1-30 months

Study Arms (2)

Childhood Acute Lymphoblastic Leukemia patients

Bone marrow mononuclear cells from childhood acute lymphoblastic leukemia of T cells

Diagnostic Test: lncRNA signature analyses

Healthy subjects

Cord blood mononuclear cells from healthy volounteers

Diagnostic Test: lncRNA signature analyses

Interventions

lncRNA signature analyses DIAGNOSTIC_TEST

Evaluation of a signature of identified lncRNA in a cohort of childhood T-ALL patients in comparison with healthy subjects.

Childhood Acute Lymphoblastic Leukemia patients; Healthy subjects

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

childhood acute lymphoblastic leukemia of T cells patients.

You may qualify if:

• Patients with a diagnosis of T-ALL 1-18 years aged of both sexes;
• Presence of leukemic cells in peripheral blood of recruited patients.

You may not qualify if:

• Patients who refuse to participate in the study;
• Patients not falling in the age group mentioned above

Sponsors & Collaborators

• IRCCS SYNLAB SDN: lead
• Fondazione Santobono Pausilipon: collaborator

Study Sites (1)

Irccs Synlab Sdn

Naples, 80143, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bone Marrow mononuclear Cells

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Giovanni Smaldone, PhD

  IRCCS SYNLAB SDN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Pierri, Master

CONTACT

0812408260; laura.pierri@synlab.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: April 30, 2023
• Primary Completion: December 31, 2023
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)