Inhibition of Che-1/AATF as a New Tool in Multiple Myelom... | NCT05858203

Studies
Inhibition of Che-1/AATF as a New Tool in Multiple Myeloma Treatment

NCT05858203

Sponsor

Regina Elena Cancer Institute

Status

Unknown status

Last Update Posted

May 15, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

ATAC-seq and ChIP-seq

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2020Actual

Primary Completion Date

Mar 21, 2023Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

May 4, 2023

First Posted Date

May 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2023

Last Update Posted Date

May 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATAC-seq and ChIP-seq	Other	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

MM Patients

Exclusion Criteria:

No exclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

MM Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maurizio fanciulli, PhD	Contact	+39 06 52662800		maurizio.fanciulli@ifo.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regina elena Cancer Institute	Active, not recruiting	Roma		00144	Italy
"Regina Elena" National Cancer Institute

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D020141	Hemostatic Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000081204	Chromatin Immunoprecipitation Sequencing

Ancestor Terms

ID	Term
D047369	Chromatin Immunoprecipitation
D005821	Genetic Techniques
D008919	Investigative Techniques
D059014	High-Throughput Nucleotide Sequencing

Browse Leaves

Not provided

Browse Branches

Not provided