Cell Free DNA in Mature B-cell Lymphoma | NCT04088422

Studies
Cell Free DNA in Mature B-cell Lymphoma

NCT04088422

Sponsor

Ruijin Hospital

Status

Recruiting

Last Update Posted

Feb 24, 2023Actual

Enrollment

320Estimated

Phase

Not provided

Conditions

Mature B-Cell Lymphoma

Interventions

peripheral blood collection

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 28, 2022Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Sep 11, 2019

First Submission Date that Met QC Criteria

Sep 11, 2019

First Posted Date

Sep 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2023

Last Update Posted Date

Feb 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

320Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
B-cell lymphoma			Procedure: peripheral blood collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
peripheral blood collection	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		2-year

Secondary Outcomes

Measure	Description	Time Frame
overall survival		2-year
Complete Response rate		6 weeks after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Chemotherapy before
Other tumors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Weili Zhao, MD，PhD	Contact	64370045	610707	zhao.weili@yahoo.com

Overall Officials

Name	Affiliation	Role
Weili Zhao, MD，PhD	Ruijin Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruijin hospital	Recruiting	Shanghai	Shanghai Municipality	200025	China