Raman Spectroscopy Compared to Flow Cytometry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-70
SponsorHospital Regional de Alta Especialidad del Bajio

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.

Disqualifiers

Patients without ALL

Trial population

Acute lymphoblastic leukemia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Raman spectroscopy

    Diagnostic test

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Raman spectroscopy1 intervention
Group B: flow citometry1 intervention

Trial outcomes

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.

Time frame
up to 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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