Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT06674850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-10-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio 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': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-03', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis', 'timeFrame': 'one year', 'description': 'Assessment of C-reactive protein to Albumin ratio(CAR) as a biomarker for acute lymphoblastic leukemia prognosis'}], 'secondaryOutcomes': [{'measure': 'Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis', 'timeFrame': 'one year', 'description': 'Assessment of systemic inflammatory index (SII) as a biomarker for acute lymphoblastic leukemia prognosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '36835490', 'type': 'RESULT', 'citation': 'di Masi A. Human Serum Albumin: From Molecular Aspects to Biotechnological Applications. Int J Mol Sci. 2023 Feb 17;24(4):4081. doi: 10.3390/ijms24044081.'}, {'pmid': '33582571', 'type': 'RESULT', 'citation': 'Tang HN, Pan BH, Wang L, Zhu HY, Fan L, Xu W, Li JY. C-reactive protein-to-albumin ratio is an independent poor prognostic factor in newly diagnosed chronic lymphocytic leukaemia: A clinical analysis of 322 cases. Transl Oncol. 2021 Apr;14(4):101035. doi: 10.1016/j.tranon.2021.101035. Epub 2021 Feb 11.'}, {'pmid': '31653664', 'type': 'RESULT', 'citation': 'Roberts KG, Mullighan CG. The Biology of B-Progenitor Acute Lymphoblastic Leukemia. Cold Spring Harb Perspect Med. 2020 Jul 1;10(7):a034835. doi: 10.1101/cshperspect.a034835.'}]}, 'descriptionModule': {'briefSummary': 'the goal of this observational study is Assesment of systemic inflammatory index (SII) , system inflammation response index (SIRI) and CRP Albumin ratio(CAR) as biomarkers for ALL prognosis.', 'detailedDescription': 'Acute lymphoblastic leukemia (ALL) results from a clonal expansion of abnormal, immature lymphoid progenitors of B cell or T cell origin that invade bone marrow (BM), peripheral blood, and extramedullary sites .\n\nThe incidence of ALL is highest among children aged 1-4 years and declines with age rising slightly after the age of 50. Several genetic alterations have been already found as drivers of ALL, uncovering the genetic heterogeneity of the disease.\n\nIt is the most common leukemia in the pediatric population, according for up to 80% of cases in this group vs. 20% of cases in adults. Treatment among adolscents and young adults is predominantly inspired by pediatric regimens with better survival rates .\n\nAcute leukemia tends to present non-specifically, although the most common presenting features include fever, lethargy, and bleeding. Hepatosplenomegaly, lymphadenopathy, and musculoskeletal symptoms (especially involving the spine and long bones) can also be clues to the diagnosis. Adults may also have more prominent anemia-related symptoms, such as shortness of breath, or symptoms related to thrombocytopenia, such as excessive bruising or increased bleeding tendency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNewly diagnosed ALL patients that admitted to the South Egypt Cancer Institute and not received any treatment.\n\nExclusion Criteria:\n\n1. Presence of other hematological disorders( other than ALL)\n2. History of other malignancies, or relapsed ALL.\n\n2- Patients under chemotherapy or radiotherapy. 3- Signs of inflammation 5- Evidence of autoimmune disease.'}, 'identificationModule': {'nctId': 'NCT06674850', 'briefTitle': 'Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Assessment of the Prognostic Role of Systemic Inflammatory Index, Systemic Inflammation Response Index and C-Reactive Protein to Albumin Ratio in Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'inflammation in leukemia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diseased group', 'description': '36 patients with acute lymphoblastic leukemia will be included'}, {'label': 'Control group', 'description': '36 healthy people will be included'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esraa Hamoda', 'role': 'CONTACT', 'email': 'esraahamoda73@gmail.com', 'phone': '+2001066177369'}], 'overallOfficials': [{'name': 'Asmaa zhran', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Doaa Temeric', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Esraa Hamoda Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}