Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06291428 |
| Other study ID # |
F-CNIC-2024-007 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2024 |
| Est. completion date |
December 30, 2026 |
Study information
| Verified date |
February 2024 |
| Source |
Hospital Regional de Alta Especialidad del Bajio |
| Contact |
Lauro F Amador Medina, PhD |
| Phone |
4772697907 |
| Email |
lafab2013[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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.
