NCT06291428 Raman Spectroscopy Compared to Flow Cytometry
| NCT ID | NCT06291428 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Regional de Alta Especialidad del Bajio |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-15 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-10-15 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study. Exclusion Criteria: * Patients without ALL
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06291428 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 70 Years, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06291428 currently recruiting?
Yes, NCT06291428 is actively recruiting participants. Contact the research team at lafab2013@gmail.com for enrollment information.
Where is the NCT06291428 trial being conducted?
This trial is being conducted at León, Mexico.
Who is sponsoring the NCT06291428 clinical trial?
NCT06291428 is sponsored by Hospital Regional de Alta Especialidad del Bajio. The trial plans to enroll 50 participants.
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