NCT04062877

Brief Summary

Lymphoma is a highly heterogeneous blood malignancy. It is very important to search for relative specific diagnostic markers that can detect related lymphoma in early stage for the treatment and long-term prognosis of the disease, as the hematopoietic diseases, such as lymphoma, are more difficult to biopsy than solid tumors, with more damage and side effects.Liquid Biopsy (Liquid Biopsy) refers to the extraction of solid biological tissue, is the most common blood, also including saliva, urine, cerebrospinal fluid and other body fluids, and extract the circulating tumor cells (circulating tumor cell, CTC) and circulating tumor DNA (circulating tumor DNA, ctDNA) is used to assess related diseases. CTCs/CSCs have the ability to generate new tumors and play a key role in tumor metastasis.This project intends to develop liquid biopsy technology for accurate diagnosis and prognosis judgment of lymphoma, to carry out clinical transformation application and serve patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2022

Enrollment Period

3.5 years

First QC Date

August 5, 2019

Last Update Submit

March 22, 2022

Conditions

Keywords

Fluid biopsylymphomaaccurate diagnosis

Outcome Measures

Primary Outcomes (2)

  • complete remission

    Patients achieve complete remission after initial treatment

    From date of randomization or initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 weeks

  • relapse

    Patients' disease progress after complete remission

    From date of randomization or complete remission until the date of first documented relapse from any cause,assessed up to 100weeks.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment, aged between 14 to 75 years.

You may qualify if:

  • patients of lymphoma diagnosed of de novo, CR, relapsed/refractory, be willing to receive treatment

You may not qualify if:

  • leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology Southeast University Department of Hematology Zhongda Hospital Southeast University Medical School

Nanjing, Jiangsu, 210000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

patients'samples from peripheral blood

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Zheng Ge

    Director of Department of Hematology Zhongda Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Hematology

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 20, 2019

Study Start

July 1, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

March 24, 2022

Record last verified: 2022-03

Locations