Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 10:28 PM
Study NCT ID:
NCT05021159
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2021-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-28', 'studyFirstSubmitDate': '2021-08-19', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P-gp expression in blood samples', 'timeFrame': '42 hours', 'description': 'P-gp expression in blood samples'}, {'measure': 'Methotrexate concentration in blood samples', 'timeFrame': '42 hours', 'description': 'Methotrexate concentration in blood samples'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '19325113', 'type': 'BACKGROUND', 'citation': 'Aller SG, Yu J, Ward A, Weng Y, Chittaboina S, Zhuo R, Harrell PM, Trinh YT, Zhang Q, Urbatsch IL, Chang G. Structure of P-glycoprotein reveals a molecular basis for poly-specific drug binding. Science. 2009 Mar 27;323(5922):1718-22. doi: 10.1126/science.1168750.'}, {'pmid': '21866921', 'type': 'BACKGROUND', 'citation': 'Namanja HA, Emmert D, Davis DA, Campos C, Miller DS, Hrycyna CA, Chmielewski J. Toward eradicating HIV reservoirs in the brain: inhibiting P-glycoprotein at the blood-brain barrier with prodrug abacavir dimers. J Am Chem Soc. 2012 Feb 15;134(6):2976-80. doi: 10.1021/ja206867t. Epub 2011 Sep 9.'}, {'pmid': '13679531', 'type': 'RESULT', 'citation': 'Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Determine P-glycoprotein expression in blood samples of Acute Lymphocytic leukemia (ALL) pediatric patients receiving MTX treatment and trace its ontogeny and compare it with its expression in pediatric healthy subjects. In addition, to determine the correlation of P-glycoprotein expression and Methotrexate concentration at steady state.', 'detailedDescription': "The 20 leukemic patients will be classified into three age groups according to the ages that will be available at the time of sample collection.\n\n* All patients will be recruited from Tanta Oncology Center, Tanta University.\n* The study will be approved by the Research Ethics Committee of Tanta University and college of Pharmacy ethical committee.\n* An informed consent will be obtained from parents of all patients in this research before enrollment.\n* All patients' data will be private and confidential. Any unexpected risks that may appear during the course of the research will be reported to patients and the ethical committee on time.\n\nBlood Samples will be obtained from healthy pediatric subjects of the same ages of the diseased group subjects (Samples will be obtained from subjects from a primary care center during their routine blood analysis excluding patients of chronic diseases, patients receiving any medications, and patients of impaired kidney or liver functions).\n\nP-glycoprotein expression will be estimated in all samples using Permeability glycoprotein (P-gp), ELISA Kit, and its expression will be traced with development from the youngest till the oldest age available, this will also be compared with normal healthy pediatric subjects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric Acute Lymphocytic Leukemia Patients aged \\< 18 years old who are already taking the ALL MTX protocol.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric Acute Lymphocytic Leukemia Patients\n* aged \\< 18 years old\n* who are already taking the ALL MTX protocol.\n\nExclusion Criteria:\n\n* Severe renal impairment (eGFR\\< 30 mL/min/1.73 m2 at screening)\n\n * Critically ill patients.\n * Other types of cancer'}, 'identificationModule': {'nctId': 'NCT05021159', 'briefTitle': 'Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Assessing the Ontogeny of P-glycoprotein Expression in Blood of Pediatric Leukemic Patients', 'orgStudyIdInfo': {'id': '141052'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Methotrexate Group', 'description': '20 acute lymphocytic leukemia patients receiving MTX treatment (3- 5 mg/ cm2)', 'interventionNames': ['Other: MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)']}, {'label': 'Healthy control group', 'description': '20 healthy pediatric subjects not receiving any treatment'}], 'interventions': [{'name': 'MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)', 'type': 'OTHER', 'description': 'the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression', 'armGroupLabels': ['Methotrexate Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31111', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Faculty of Pharmacy, Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '31111', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta Cancer Center', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}, {'zip': '31111', 'city': 'Tanta', 'state': 'Gharbia Governorate', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Yasmine M Elmorsi, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University'}, {'name': 'Osama M Ibrahim, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University'}, {'name': 'Tarek M Mostafa, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant Professor in Clinical Pharmacy Dept., Faculty of pahrmacy, Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yasmine Elmorsi', 'investigatorAffiliation': 'Tanta University'}}}}