Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
Study NCT ID:
NCT06291428
Status:
RECRUITING
Last Update Posted:
2025-03-12
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Raman Spectroscopy Compared to Flow Cytometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurable residual disease', 'timeFrame': 'up to 1 year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': '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).\n\nObjectives:\n\nMAIN OBJECTIVE:\n\nTo 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.\n\nSPECIFIC OBJECTIVES:\n\n* To assess the presence of MRD using flow cytometry in patients with ALL.\n* To assess the presence of MRD using Raman spectroscopy in patients with ALL.\n* To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.\n* To establish the validation of using Raman spectroscopy as a method for MRD evaluation.\n\nStudy Design:\n\nAn 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.\n\nInclusion Criteria:\n\nPatients 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.', 'detailedDescription': '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.\n\nObjectives:\n\nMAIN OBJECTIVE:\n\nTo 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.\n\nSPECIFIC OBJECTIVES:\n\n* To assess the presence of MRD using flow cytometry in patients with ALL.\n* To assess the presence of MRD using Raman spectroscopy in patients with ALL.\n* To perform a comparison between the MRD measurement techniques by determining sensitivity, specificity, positive predictive value, and negative predictive value.\n* To establish the validation of using Raman spectroscopy as a method for MRD evaluation.\n\nStudy Design:\n\nAn 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.\n\nInclusion Criteria:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute lymphoblastic leukemia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with ALL for whom MRD determination is clinically necessary will be included in the study.\n\nExclusion Criteria:\n\n* Patients without ALL'}, 'identificationModule': {'nctId': 'NCT06291428', 'briefTitle': 'Raman Spectroscopy Compared to Flow Cytometry', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Regional de Alta Especialidad del Bajio'}, 'officialTitle': 'Raman Spectroscopy Compared to Flow Cytometry as a Method for Assessing Measurable Residual Disease in Patients With Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'F-CNIC-2024-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Raman spectroscopy', 'description': 'Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.', 'interventionNames': ['Diagnostic Test: Raman spectroscopy']}, {'label': 'flow citometry', 'description': 'Patients with acute lymphoblastic leukemia, in assessment for measure residual disease.', 'interventionNames': ['Diagnostic Test: Raman spectroscopy']}], 'interventions': [{'name': 'Raman spectroscopy', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Raman spectroscopy', 'flow citometry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37660', 'city': 'León', 'state': 'Guanajuato', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Lauro F Amador, Researcher', 'role': 'CONTACT', 'email': 'lafab2013@gmail.com', 'phone': '477 2672000', 'phoneExt': '1512'}], 'facility': 'Hospital Regional Alta Especialidad Bajio', 'geoPoint': {'lat': 21.12908, 'lon': -101.67374}}], 'centralContacts': [{'name': 'Lauro F Amador Medina, PhD', 'role': 'CONTACT', 'email': 'lafab2013@gmail.com', 'phone': '4772697907'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Regional de Alta Especialidad del Bajio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Lauro Fabian Amador Medina', 'investigatorAffiliation': 'Hospital Regional de Alta Especialidad del Bajio'}}}}