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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05858203
Other study ID # RS1442/20
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 22, 2020
Est. completion date December 31, 2025

Study information

Verified date March 2023
Source Regina Elena Cancer Institute
Contact Maurizio fanciulli, PhD
Phone +39 06 52662800
Email maurizio.fanciulli@ifo.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Multiple myeloma (MM) is a haematological malignancy characterized by the accumulation of proliferating antibody producing plasma cells in the bone marrow. In the last few years many studies have emphasized the biological complexity and heterogeneity of MM as a result of both genetic and epigenetic aberrations. Che-1/AATF (Che-1) is a transcriptional cofactor involved in cell cycle regulation, apoptosis, DNA damage and stress response. it can be hypothesized that Che-1 might contribute to the establishment of the MM malignant phenotype by sustaining global transcription through its ability to modulate chromatin accessibility. The prospective study on MM human samples aims to understand the involvement of Che-1 in the transcriptional regulation and chromatin remodeling during the pathology. To this goal the main objectives are: - Characterization of Che-1's role in chromatin remodeling and global gene expression - Study in vivo and in vitro of Che-1 involvement in MM tumorigenesis - Evaluation of Che-1 as a possible therapeutic target


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date March 21, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - MM Patients Exclusion Criteria: - No exclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ATAC-seq and ChIP-seq
CD138+ cells will be isolated from the bone marrow of MM patients and will be subjected to ATAC-seq and ChIP-seq analyses, by useing specific antibodies, to better understand the involvment of Che-1 in MM tumorogenesis.

Locations

Country Name City State
Italy Regina elena Cancer Institute Roma
Italy "Regina Elena" National Cancer Institute Rome

Sponsors (1)

Lead Sponsor Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Che-1 involvement in MM tumorigenesis Characterization of Che-1's role in chromatin remodeling and global gene expression About 2 years
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