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The application of unique molecular identifier labeled super depth next generation sequencing in minimal residential disease detection of pediatric acute leukemia

The application of unique molecular identifier labeled super depth next generation sequencing in minimal residential disease detection of pediatric acute leukemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027655
Enrollment
Unknown
Registered
2019-11-23
Start date
2019-11-25
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leukemia

Interventions

Gold Standard:Clinical outcome and laboratory index
Index test:unique&#32
identifier&#32
labeled&#32
super&#32
sequencing

Sponsors

Children's Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) the diagnosis of acute leukemia was confirmed and the typing test was improved. Before the admission, the patients had not received any anti-tumor treatment including hormone. (2) at the time of diagnosis, LAIP, leukemia fusion gene and Wes sequencing were found. (3) be able to receive treatment and bone marrow examination evaluation according to the standard treatment plan. (4) the age of the unit is 0-18 years old (including boundary value); (5) agree with the examination plan and follow-up plan specified in the clinical trial plan, and actively cooperate; (6) the guardian of the patient agrees to participate in the clinical trial and sign ICF, indicating that he understands the purpose and procedure of the clinical trial and is willing to participate in the study. Patients = 8 years old signed ICF with the consent of their guardian, indicating that they understood the purpose and procedure of this clinical trial and were willing to participate in the study.

Exclusion criteria

Exclusion criteria: (1) secondary acute leukemia, such as chronic myeloid leukemia, myelodysplastic syndrome related leukemia, primary immunodeficiency disease-related leukemia; (2) previous history of tumor diseases; (3) other conditions that are not suitable to participate in the study or affect the analysis of the results of the clinical study.

Design outcomes

Primary

MeasureTime frame
MRD level;Event free survival;SPE, SEN, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactJianwen Xiao

Children's Hospital of Chongqing Medical University

tomahawk6502@sohu.com+86 13527449631

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026