Compares Raman spectroscopy with flow cytometry for finding leftover leukemia cells
Tests a light-based method against standard testing for leftover leukemia cells.
Plain-language title generated from the registry record
Registry title: Raman Spectroscopy Compared to Flow Cytometry
Key facts
- Where
- León, MexicoSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 70 years old?
Source: NCT06291428, who can take part
Where in Mexico
- Hospital Regional Alta Especialidad BajioLeón, MexicoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital Regional de Alta Especialidad del Bajio
- Trial code
- NCT06291428
- Record updated
- 12 March 2025
- Original description
The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).Read full original descriptionShow less
Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia
The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with acute lymphoblastic leukemia (ALL). However, it has a sensitivity level that detects one leukemic cell in 10,000 normal cells, along with other disadvantages such as the need for a panel of fluorescent antibodies for MRD detection, and its measurement is not standardized in many centers. New determination techniques may be necessary for MRD evaluation. Raman spectroscopy is proposed as a potential technique for MRD measurement, which is based on the inelastic scattering of light that occurs when it interacts with matter, causing optical scattering, where a portion of the radiation changes its wavelength (by Raman effect).
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.
Inclusion: Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.
Exclusion: Patients without ALL.