Next Generation Sequencing（NGS）Monitors Minimal Residual Disease（MRD）in Allo-PBSCT Patients

NCT04126967 | Unknown

• 1 other identifier: SHSYXY- NGS-2019003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: to evaluate the value of high-throughput next generation gene sequencing (NGS) in the detection of minimal residual disease (MRD) and recurrence after allogeneic transplantation. Overview of study design. This study is a single-center, single-arm, prospective clinical trial designed to evaluate the significance of next generation gene sequencing (NGS) in monitoring for minimal residual disease (MRD) and recurrence after allogeneic transplantation. This clinical study is observational and does not involve drugs. Next generation sequencing (NGS) were used to monitor minor residual lesions after allogeneic hematopoietic stem cell transplantation, to predict disease recurrence early, and to monitor and evaluate prognosis, so as to provide basis for early intervention treatment after transplantation, so as to reduce hematological recurrence and improve survival rate. This clinical study is observational and does not involve drugs.The sensitive next generation sequencing (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation, to predict the relapse of the disease in the early stage, and to monitor and evaluate the prognosis, so as to provide the basis for early intervention treatment after transplantation, so as to reduce the hematological relapse and improve the survival rate.

Conditions

NGS Monitor MRD

Keywords

NGS; MRD; Allo-PBSCT

Outcome Measures

Primary Outcomes (5)

• NGS results

  positive: VAF\>0.2%; negative: VAF \<0.1%

  3 years

• MRD by FCM

  posotive：MRD by FCM≥0.01%， negative:MRD by FCM\<0.01%

  3 years

• Donor chimerism (DC)

  positive: the chimerism rate increased ((STR \< 90%) or FISH \> 0.6%);negative:chimerism rate reached(STR \> 95% or xy-FISH Donor chromosome \> 99.4%)

  3 years

• fusion gene or WT1

  positive:WT1/ reference gene, bone marrow \>2%;negative:negative fusion gene, WT1/ reference gene \<0.6%.

  3 years

• relapse

  The number of patients relapse after Allo-PBSCT

  3 years

Secondary Outcomes (1)

• survival

  3 years

Study Arms (1)

allo-PBSCT patients with no NGS text

OTHER

Diagnostic Test: NGS patients

Interventions

NGS patients DIAGNOSTIC_TEST

The next generation sequencing technique (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation

allo-PBSCT patients with no NGS text

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old, male or female;
• Patients who received allogeneic peripheral blood hematopoietic stem cell transplantation ;
• Patients must be able to understand and be willing to participate in this study and sign informed consent.-

You may not qualify if:

• Non-allogeneic hematopoietic stem cell transplantation patients;
• The expected survival rate is less than 3 months after transplantation;

Sponsors & Collaborators

• Xianmin Song, MD: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief of hematology

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 15, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

CN (1)