NCT05858203

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2.2 years

First QC Date

March 24, 2023

Last Update Submit

May 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Che-1 involvement in MM tumorigenesis

    Characterization of Che-1's role in chromatin remodeling and global gene expression

    About 2 years

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MM Patients

You may qualify if:

  • MM Patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regina elena Cancer Institute

Roma, 00144, Italy

ACTIVE NOT RECRUITING

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Chromatin Immunoprecipitation Sequencing

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Chromatin ImmunoprecipitationGenetic TechniquesInvestigative TechniquesHigh-Throughput Nucleotide SequencingSequence AnalysisSequence Analysis, DNAImmunoprecipitationImmunologic Techniques

Central Study Contacts

Maurizio fanciulli, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 15, 2023

Study Start

December 22, 2020

Primary Completion

March 21, 2023

Study Completion

December 31, 2025

Last Updated

May 15, 2023

Record last verified: 2023-03

Locations