Acute Lymphoblastic LeukemiaNCT06291428
Raman Spectroscopy Compared to Flow Cytometry
An observational study of Acute Lymphoblastic Leukemia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
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… Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Raman spectroscopy
- How many people
- 50 participants
- Where
- 1 siteMexico
- Study dates
- 15 Oct 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Acute lymphoblastic leukemia
Who may be able to join
- Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.
Who cannot join
- Patients without ALL
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional Alta Especialidad Bajio
León, Guanajuato, 37660
Lauro F Amador, Researcher, 477 2672000 ext. 1512, lafab2013@gmail.com
About this study
Official title: Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia
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:
Read more
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.
Read the detailed 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Raman spectroscopy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman spectroscopyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Raman spectroscopy | Patients with acute lymphoblastic leukemia, in assessment for measure residual disease. Receives: Diagnostic Test: Raman spectroscopy | |
| flow citometry | Patients with acute lymphoblastic leukemia, in assessment for measure residual disease. Receives: Diagnostic Test: Raman spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauro Fabian Amador Medina, Hospital Regional de Alta Especialidad del Bajio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291428
- Sponsor's protocol ID
- F-CNIC-2024-007
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06291428
- Acronym / sponsor ID
- F-CNIC-2024-007
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raman spectroscopy | – | Diagnostic Test: Raman spectroscopyPatients with acute lymphoblastic leukemia, in assessment for measure residual disease. |
| flow citometry | – | Diagnostic Test: Raman spectroscopyPatients with acute lymphoblastic leukemia, in assessment for measure residual disease. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Acute lymphoblastic leukemia
Key inclusion criteria (1 listed)
- Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.
Key exclusion criteria (1 listed)
- Patients without ALL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman spectroscopyRaman 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. | Diagnostic test | Raman spectroscopy, flow citometry |
Primary outcome
measurable residual disease
Time frame: up to 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauro F Amador Medina, PhD (4772697907, lafab2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurable residual disease (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.