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

Accuracy of a flexible nanodevice based on DNA probes and conductive polymers for ultrasensitive diagnosis of chimeric oncogenes associated with childhood Lymphocytic Leukemia in health units in Brazil and therapeutic decision under the Brazilian Childhood Leukemia Treatment Group (GBTLI) protocol - 2020

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-10t3wc7z
Enrollment
Unknown
Registered
2023-08-18
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Lymphoblastic Leukemia

Interventions

This is a study to evaluate a new diagnostic device. In the first stage, the patients bone marrow samples will be collected and assessed for the presence of chimeric genes by the conventional PCR meth

Sponsors

Instituto Aggeu Magalhães - Fiocruz de Pernambuco
Lead Sponsor
Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
Collaborator
Universidade Federal de Pernambuco
Collaborator

Eligibility

Age
No minimum to 20 Years

Inclusion criteria

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

Exclusion criteria: Patients with mature B-cell Leukaemia

Design outcomes

Primary

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

Secondary

MeasureTime frame
No secondary outcomes expected

Countries

Brazil

Contacts

Public ContactNorma Lucena-Silva

Fundação Oswaldo Cruz de Pernambuco

norma.silva@fiocruz.br+55(81)21012618

Outcome results

None listed

Source: REBEC (via WHO ICTRP)