Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

NCT ID: NCT05888636

Last Updated: 2024-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-18

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MGUS

ChIP-seq, NGS, ATAC-seq

Intervention Type OTHER

Bone narrow sampling

MM smouldering

ChIP-seq, NGS, ATAC-seq

Intervention Type OTHER

Bone narrow sampling

Syntomatic MM

ChIP-seq, NGS, ATAC-seq

Intervention Type OTHER

Bone narrow sampling

Interventions

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ChIP-seq, NGS, ATAC-seq

Bone narrow sampling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Compare Transcriptomics and epigenetic profile
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role collaborator

University of Rome Tor Vergata

OTHER

Sponsor Role collaborator

Sant'Eugenio Hospital, Rome

UNKNOWN

Sponsor Role collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurizio Fanciulli, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

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Regina elena Cancer Institute

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maurizio Fanciulli, PhD

Role: CONTACT

*39 06 52662800

Facility Contacts

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Maurizio Fanciulli, PhD

Role: primary

06-52662800

Other Identifiers

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RS1237

Identifier Type: -

Identifier Source: org_study_id

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