Raman Spectroscopy Compared to Flow Cytometry
1 other identifier
observational
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 4, 2024
CompletedStudy Start
First participant enrolled
October 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
March 12, 2025
March 1, 2025
2.2 years
February 23, 2024
March 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
measurable residual disease
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.
up to 1 year
Study Arms (2)
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.
Interventions
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). By analyzing the inelastically scattered light, we can obtain a Raman spectrum formed by the intensity of the scattered light as a function of its vibration frequency, thus obtaining information about the biochemical composition of a biological sample.
Eligibility Criteria
Acute lymphoblastic leukemia
You may qualify if:
- Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.
You may not qualify if:
- Patients without ALL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Regional Alta Especialidad Bajio
León, Guanajuato, 37660, Mexico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 23, 2024
First Posted
March 4, 2024
Study Start
October 15, 2024
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
March 12, 2025
Record last verified: 2025-03