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Multicenter clinical study on DLBCL MRD monitoring using ctDNA-IgNGS.

Multicenter clinical study on DLBCL MRD monitoring using ctDNA-IgNGS.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087307
Enrollment
Unknown
Registered
2024-07-24
Start date
2022-10-27
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DLBCL

Interventions

A: Newly diagnosed large B-cell lymphoma:No
B: Patients with relapsed, refractory or newly diagnosed large B-cell lymphoma who are preparing for hematopoietic stem cell transplantation or CAR-T therapy:No

Sponsors

Hematology Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: To be eligible for inclusion in this study, subjects must meet all of the following criteria: 1) Patients fully understand this study, voluntarily participate and sign the informed consent; 2) The age is greater than 18 years old, and the gender is not limited; 3) Newly diagnosed large B-cell lymphoma confirmed by histopathology, or patients with relapsed or refractory large B-cell lymphoma who are ready to receive hematopoietic stem cell transplantation or CAR-T therapy; 4) There must be at least 1 evaluable or measurable lesion that meets Lugano2014 criteria; 5) Able to cooperate with the collection of samples from each node and provide corresponding clinical information.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are not eligible for this study: 1) Active hepatitis B, hepatitis C infection or human immunodeficiency virus (HIV) infection; 2) Suffering from other lymphoid malignancies at the same time 3) Patients who are judged by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
sensitivity;specificity;PPV;NPV;

Countries

China

Contacts

Public ContactQiu Lugui

Hematology Hospital, Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

qiulg@ihcams.ac.cn+86 138 2126 6636

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026