Raman Spectroscopy Compared to Flow Cytometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2026-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

NCT01298414

Leukemia

COMPLETED

Efficacy of the Use of Bortezomib for the Treatment of Relapsed Leukemia or Positive MRD

NCT05137860

Minimal Residual Disease Acute Lymphoblastic Leukemia, in Relapse Chemotherapeutic Toxicity

UNKNOWN PHASE4

Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT01142427

Acute Lymphoblastic Leukemia

COMPLETED

Real-World Disease Management and Outcomes in Chronic Myeloid Leukaemia

NCT05893836

Chronic Myeloid Leukaemia

COMPLETED

Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia

NCT01232842

Leukemia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The assessment of measurable residual disease (MRD) is a frequent practice in the management of acute lymphoblastic leukemia (ALL). The detection of MRD is associated with an increased risk of relapse and adverse prognosis in all patient groups diagnosed with ALL. The three approved methods for MRD measurement are flow cytometry, polymerase chain reaction (PCR) of specific mutations, and next-generation sequencing (NGS). Of these, flow cytometry is the most used method in clinical practice. 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). 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.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Raman spectroscopy

Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.

Raman spectroscopy

Intervention Type 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.

flow citometry

Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.

Raman spectroscopy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Raman spectroscopy

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.

Intervention Type DIAGNOSTIC_TEST