Cell Free DNA in Mature B-cell Lymphoma

Mature B-Cell Lymphoma Clinical Trial

Official title:

Prospective, Observational Study on Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Lymphoma Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088422
• Other study ID #: cfDNA
• Status: Recruiting
• Start date: September 28, 2022
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Ruijin Hospital
• Contact: Weili Zhao, MD,PhD
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess whether plasma cell free DNA is an accurate tool that can early and dynamically inform on treatment outcome and an accessible source of tumor DNA to track tumor clonal evolution.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria

• 18 years or older

Exclusion Criteria:

• Chemotherapy before

• Other tumors

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Mature B-Cell Lymphoma

Intervention

Procedure:
• peripheral blood collection
peripheral blood collection at treatment start, interm PET/CT, end of treatment PET/CT, one-year and two-year follow-up and or progression or relapse

Locations

Country	Name	City	State
China	Ruijin hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression free survival		2-year
Secondary	overall survival		2-year
Secondary	Complete Response rate		6 weeks after treatment