Transcriptomics and Epigenetics Analysis in Drug-Resistan... | NCT05888636

Studies
Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

NCT05888636

Sponsor

Regina Elena Cancer Institute

Status

Unknown status

Last Update Posted

Mar 22, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Multiple Myeloma

Interventions

ChIP-seq, NGS, ATAC-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 2024

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

Jun 18, 2019Actual

Primary Completion Date

Nov 11, 2023Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Mar 24, 2023

First Submission Date that Met QC Criteria

May 24, 2023

First Posted Date

Jun 5, 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

Mar 20, 2024

Last Update Posted Date

Mar 22, 2024Actual

Name	Class
Campus Bio-Medico University	OTHER
University of Rome Tor Vergata	OTHER
S.Eugenio Hospital	OTHER

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 the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity.

The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.

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

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MGUS			Other: ChIP-seq, NGS, ATAC-seq
MM smouldering			Other: ChIP-seq, NGS, ATAC-seq
Syntomatic MM			Other: ChIP-seq, NGS, ATAC-seq

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ChIP-seq, NGS, ATAC-seq	Other	Bone narrow sampling	MGUS MM smouldering Syntomatic MM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples	Characterize genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.	12 months
Epigenetics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples	Quantify genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement.	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Compare Transcriptomics and epigenetic profile

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

For the study, samples from patients with MGUS, MM smouldering and syntomatic MM will be used

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

Name	Affiliation	Role
Maurizio Fanciulli, PhD	IRCCS "Regina Elena" National Cancer Institute	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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