Development and evaluation of flexible sensor devices and construction of plasmid positive controls for molecular diagnosis and detection of residual disease in Leukemia

• Conditions: ymphoblastic Leukemia; C95.9

• Registration Number: RBR-10t3wc7z
• Lead Sponsor: Instituto Aggeu Magalhães - Fiocruz de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-08-18
• Last Update Posted: 18 September 2023
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with a maximum age of 20 years; both genders; attended at reference services for the treatment of leukemia in Brazil with a clinical and cytological diagnosis of leucemia; who express the desire to participate in the project and the legal guardians sign the Free and Informed Consent Form and the children between 8 and 18 years old sign the Free and Informed Assent Term, providing clinical information, and allowing the analysis of samples (bone marrow) in the laboratory reference of the study in Recife

Exclusion Criteria

Patients with mature B-cell Leukaemia

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the accuracy and effectiveness of molecular qPCR testing for detecting measurable residual disease by harmonizing test performance parameters performed in different laboratories

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes expected