Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-02 @ 11:59 PM
Study NCT ID:
NCT05943093
Status:
UNKNOWN
Last Update Posted:
2023-07-13
First Post:
2023-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
H19 in Acute Lymphoblastic Leukemia.
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.', 'timeFrame': 'baseline'}], 'secondaryOutcomes': [{'measure': 'Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.', 'timeFrame': 'baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoid Leukemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/36680478/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '* Study the expression level of H19 gene in the samples from ALL patients by real-time PCR.\n* Correlate the expression level of H19 gene with the clinical presentation and laboratory data of those patients.', 'detailedDescription': 'Acute lymphoblastic leukemia (ALL) is the most common cancer affecting children and adolescents (Zeng XL et al, 2023). ALL is a haematological malignancy characterized by the malignant clonal expansion of lymphoid hematopoietic precursors (Hong Z et al, 2021). It arises from B- or T-lineage lymphoid progenitors: B-cell-precursor ALL (B-ALL) and T-cell ALL (T-ALL) (Brady SW et al., 2022). Rrelapse in ALL is the fundamental cause of treatment failure in 15-20% of patients (Hulleman E et al, 2009). Therefore, the exploration of novel functional molecules that play a role in ALL pathogenesis could be effective therapeutic targets for this disease (Asadi M et al, 2023).\n\nLong non-coding RNAs (lncRNAs) are non-protein coding transcripts longer than 200 nucleotides (Kopp F et al, 2018). H19 was the first lncRNA to be discovered and submitted for genomic imprinting (Yoshimura H et al, 2018). It has a role in embryogenesis and tumorigenesis (Yoshimura H et al, 2014). It also has an indispensable role in enhancing cell proliferation, differentiation, migration, invasion, and chemo resistance (Li Y et al, 2020). Recent evidence has shown that H19 is an oncogene and is overexpressed in breast, liver, endometrial, lung, cervical, and esophageal cancers (Asadi M et al, 2023). A similar pattern of H19 expression was observed in various types of leukemias, including chronic myeloid leukemia (CML) (Morlando M et al, 2015) and acute myeloid leukemia (AML) (Zhang Tj et al, 2018).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'newly diagnosed ALL patients', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed ALL patients.\n\nExclusion Criteria:\n\n\\- 1-Presence of other haematological disorders, history of other malignancies or relapsed ALL.\n\n2-Patients under chemotherapy or radiotherapy.'}, 'identificationModule': {'nctId': 'NCT05943093', 'briefTitle': 'H19 in Acute Lymphoblastic Leukemia.', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Expression of Long Non-Coding RNA H19 in Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'PCR in acute leukemia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALL patients'}, {'label': 'control group free from the disease'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fatma Refaat Ibrahim', 'role': 'CONTACT', 'email': 'drfatmarefaat@gmail.com', 'phone': '01032073035'}, {'name': 'Hosney Badrawy Hamed, professor', 'role': 'CONTACT', 'email': 'Badrawy@yahoo.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Fatma Refaat Ibrahim Ismail', 'investigatorAffiliation': 'Assiut University'}}}}