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NCT06291428

Raman Spectroscopy Compared to Flow Cytometry

Recruiting now Last updated 12 March 2025
What this trial tests

trial testing Raman spectroscopy in Acute Lymphoblastic Leukemia in 50 participants. Currently enrolling.

Timeline
15 October 2024
Primary endpoint
30 December 2026
30 December 2026

Quick facts

Lead sponsorHospital Regional de Alta Especialidad del Bajio
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment50
Start date15 October 2024
Primary completion30 December 2026
Estimated completion30 December 2026
Sites1 location across Mexico

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Regional de Alta Especialidad del Bajio

Who can join

Adults 2 to 70, any sex, with Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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). 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Raman spectroscopy

Trials testing the same drug.

Other recruiting trials for Acute Lymphoblastic Leukemia

Currently open trials in the same condition.

Other Hospital Regional de Alta Especialidad del Bajio trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06291428.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing