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Cell Free DNA in Mature B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04088422
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

Brief 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.

Condition or disease Intervention/treatment
Mature B-Cell Lymphoma Procedure: peripheral blood collection

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Study on Cell Free DNA Genotyping as a Tool to Inform Mature B-cell Lymphoma Management
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
B-cell lymphoma 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

Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2-year ]
  2. Complete Response rate [ Time Frame: 6 weeks after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of mature B-cell tumor according to WHO 2008 criteria without any previous treatment in Ruijin Hospital would be included.

Inclusion Criteria:

  • Documented diagnosis of mature B-cell tumor according to WHO 2008 criteria
  • 18 years or older

Exclusion Criteria:

  • Chemotherapy before
  • Other tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04088422

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Contact: Weili Zhao, MD,PhD 64370045 ext 610707

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China, Shanghai
Ruijin hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Pengpeng XU, MD, PhD    86-21-64370045 ext 610707   
Principal Investigator: Weili ZHAO, MD, PhD         
Sub-Investigator: Pengpeng XU, MD, PhD         
Sponsors and Collaborators
Ruijin Hospital
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Principal Investigator: Weili Zhao, MD,PhD Ruijin Hospital
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Responsible Party: Zhao Weili, Professor, Ruijin Hospital Identifier: NCT04088422    
Other Study ID Numbers: cfDNA
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin