Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Objectives: MAIN OBJECTIVE: To evaluate the presence of MRD in patients with ALL by comparing a standard evaluation method using flow cytometry with a new proposed method using Raman spectroscopy. SPECIFIC OBJECTIVES: * To assess the presence of MRD using flow cytometry in patients with ALL. * To assess the presence of MRD using Raman spectroscopy in patients with ALL. * To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value. * To establish the validation of using Raman spectroscopy as a method for MRD evaluation. Study

Design: An observational, cross-sectional, comparative, and diagnostic test study will be conducted on bone marrow aspirate samples from adult and pediatric ALL patients to evaluate the presence of MRD using Raman spectroscopy, comparing the results of this technique with those obtained using flow cytometry. As a diagnostic test study, sensitivity, specificity, positive predictive value, and negative predictive value will be evaluated. The study will be conducted on adult and pediatric patients diagnosed with acute lymphoblastic leukemia treated at the hemato-oncology department of the UMAE No. 1 National Medical Center Bajio and the UMAE Hospital Gynecology-Pediatrics No. 48. Inclusion Criteria: Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Their results will be evaluated using the gold standard, flow cytometry, and compared with results obtained through Raman spectroscopy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 70
View:

• Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.

Locations
Other Locations
Mexico
Hospital Regional Alta Especialidad Bajio
RECRUITING
León
Contact Information
Primary
Lauro F Amador Medina, PhD
lafab2013@gmail.com
4772697907
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 50
Treatments
Raman spectroscopy
Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.
flow citometry
Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.
Sponsors
Leads: Hospital Regional de Alta Especialidad del Bajio

This content was sourced from clinicaltrials.gov