Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma

NCT ID: NCT05693012

Last Updated: 2023-01-20

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

UNKNOWN

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-12-31

Brief Summary

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It is an observational, case-control study aimed at early-detection of multiple myeloma and constructing a prognostic model of multiple myeloma. The study will enroll approximately 398 participants including patients with multiple myeloma, patients with benign hematologic disorders and healthy participants.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cancer Arm

participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.

cfDNA methylation assessment

Intervention Type DIAGNOSTIC_TEST

An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

Benign Arm

Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.

cfDNA methylation assessment

Intervention Type DIAGNOSTIC_TEST

An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

Healthy arm

Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

cfDNA methylation assessment

Intervention Type DIAGNOSTIC_TEST

An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

Interventions

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cfDNA methylation assessment

An exploratory study to establish the early detection and prognosis models of multiple myeloma patients in China based on plasma cf DNA methylation assessment

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 40-75 years
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of multiple myeloma or highly suspicious cases of multiple myeloma
* No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw


* Age 40-75 years
* Ability to provide a written informed consent
* Pathologically confirmed diagnosis of benign hematologic disorders or highly suspicious cases with benign hematologic disorders
* No prior or ongoing radical treatment of the benign hematologic disorders prior to study blood draw


* Age 40-75 years
* Ability to provide a written informed consent
* No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw

Exclusion Criteria

* Insufficient qualified blood samples
* Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant
* Recipient of blood transfusion within 7 days prior to blood draw
* Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen)


• Other current malignant diseases or multiple primary tumors


• Current or history of malignancies


* Recipient of anti-infectious therapy within 14 days prior to study blood draw
* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Current autoimmune disease or clinically significant or uncontrolled comorbidities
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Qiu Lugui

OTHER

Sponsor Role lead

Responsible Party

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Qiu Lugui

Director of lymphoma & myeloma center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Lugui Qiu, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

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National Clinical Research Center for Blood Diseases, Blood Diseases Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lugui Qiu, MD, Ph.D

Role: CONTACT

Mu Hao, Ph.D

Role: CONTACT

Facility Contacts

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Lugui Qiu, MD, Ph.D

Role: primary

Other Identifiers

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RSCD2022004

Identifier Type: -

Identifier Source: org_study_id

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