Clinical trial · Observational
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Multiple Myeloma
Assessment of Early Detection and Prognosis Based on cfDNA Methylation in Myeloma: a Proof of Concept Study
NCT05693012CI-TRIAL-00063347unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cfDNA methylation assessment | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cancer Arm
- description
- participants with newly diagnosed multiple myeloma, from whom blood samples will be collected.
- interventionNames
- Diagnostic Test: cfDNA methylation assessment
- label
- Benign Arm
- description
- Participants with newly diagnosed benign hematologic disorders, from whom blood samples will be collected.
- interventionNames
- Diagnostic Test: cfDNA methylation assessment
- label
- Healthy arm
- description
- Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.
- interventionNames
- Diagnostic Test: cfDNA methylation assessment
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.