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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 40 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for Cancer Participants:

  • - 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.
Inclusion Criteria for Benign Disease Participants:
  • - 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.
Inclusion Criteria for Healthy Participants.
  • - 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 for All Participants:
  • - 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) Additional Exclusion Criteria for Cancer Participants: • Other current malignant diseases or multiple primary tumors.
Additional Exclusion Criteria for Benign Disease Participants: • Current or history of malignancies. Additional Exclusion Criteria for Healthy Participants:
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05693012
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Qiu Lugui
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Lugui Qiu, MD, Ph.D
Principal Investigator Affiliation Chinese Academy of Medical Sciences & Peking Union Medical College
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma
Arms & Interventions

Arms

: Cancer Arm

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

: Benign Arm

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

: Healthy arm

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

Interventions

Diagnostic Test: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Tianjin, Tianjin, China

Status

Recruiting

Address

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

Tianjin, Tianjin, 300020

Site Contact

Lugui Qiu, MD, Ph.D

qiulg@ihcams.ac.cn

23909172

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