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NCT06291428
Raman Spectroscopy Compared to Flow Cytometry
trial testing Raman spectroscopy in Acute Lymphoblastic Leukemia in 50 participants. Currently enrolling.
30 December 2026
Quick facts
| Lead sponsor | Hospital Regional de Alta Especialidad del Bajio |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 15 October 2024 |
| Primary completion | 30 December 2026 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Raman spectroscopy
Conditions studied
- Acute Lymphoblastic Leukemia — all drugs for Acute Lymphoblastic Leukemia →
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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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06291428 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Regional de Alta Especialidad del Bajio
- Last refreshed: 12 March 2025
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