NCT04088422

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Sep 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Sep 2022Dec 2026

First Submitted

Initial submission to the registry

September 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
3 years until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

September 11, 2019

Last Update Submit

February 23, 2023

Conditions

Mature B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    2-year

Secondary Outcomes (2)

  • overall survival

    2-year

  • Complete Response rate

    6 weeks after treatment

Study Arms (1)

B-cell lymphoma

Procedure: peripheral blood collection

Interventions

peripheral blood collectionPROCEDURE

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

B-cell lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Chemotherapy before
  • Other tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Study Officials

  • Weili Zhao, MD，PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weili Zhao, MD，PhD

CONTACT

64370045zhao.weili@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 11, 2019

First Posted

September 12, 2019

Study Start

September 28, 2022

Primary Completion

December 1, 2024

Study Completion (Estimated)

December 1, 2026

Last Updated

February 24, 2023

Record last verified: 2023-02

Locations

CN(1)