Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04669418
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2020-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Host RNA Signature in Children With Cancer and Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'All children will have 2.5 ml whole blood drawn into a PaxGene RNA (Qiagen®) tube along with routine blood tests. Only RNA is extracted'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2020-12-09', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RNA signature', 'timeFrame': '1.5 years', 'description': 'To detect specific RNA signatures in whole blood in children with febrile neutropenia'}], 'secondaryOutcomes': [{'measure': 'Time study', 'timeFrame': '1,5 years', 'description': 'An investigation of the change in RNA expression over time during an infection period'}, {'measure': 'Application of known RNA signatures', 'timeFrame': '1,5 years', 'description': 'To test RNA signatures from genes published in other studies eg. the genes IFI44L and FAM89A'}, {'measure': 'Differences in RNA signature according to pathogen', 'timeFrame': '1,5 years', 'description': 'To investigate potential differences in RNA signatures in patients with gram positive versus gram negative bacteria'}, {'measure': 'Comparishment of RNA signatures in neutropenic and non-neutropenic children', 'timeFrame': '1,5 years', 'description': 'To compare RNA signatures in febrile neutropenic and non-neutropenic children with a positive blood culture'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Childhood Cancer', 'Infection', 'Neutropenia, Febrile']}, 'descriptionModule': {'briefSummary': 'The aim is to investigate if RNA expression signature can discriminate bacterial from viral infection or non-infectious inflammation in children with cancer.\n\nEarlier studies in immunocompetent children have shown promising results, but studies in immunocompromised children are lacking.\n\nWe aim to include 300 febrile episodes in children with cancer. The samples will be analysed by RNA sequencing. If succesfull, this method can help prevent unnecessary antibiotic treatment, reduce hospital admissions, side effects and antimicrobial resistance and improve quality of life for children during cancer treatment.', 'detailedDescription': 'Children with cancer are at high risk of invasive bacterial infections particularly during neutropenia. Febrile neutropenia is an early sign of a potentially fatal infection requiring broad-spectrum empiric antibiotics. However, the majority of children do not have a bacterial infection, but still receive antibiotics, since current tests cannot distinguish causes of fever. A number of transcriptomic studies of immunocompetent patients show that host leukocyte patterns of activated RNA can discriminate bacterial infection from non-infectious inflammation with high accuracy, but studies in immunocomprised patients are few.\n\nMethods\n\nA prospective non-interventional observational multicentre study including febrile childhood cancer patients during 24 months at all Danish Pediatric Oncology Departments (Rigshospitalet, Aarhus, Odense and Aalborg University Hospitals). Leukocyte RNA expression will be analysed in whole blood samples by RNA sequencing adjusted for low RNA input. 300 febrile episodes will be included, and predictive host RNA signatures will be identified in a discovery cohort and assessed in a validation cohort. Further, to explore the transcriptome in non-febrile children with neutropenia, we include a control group of 15 children with cancer and no fever.\n\nTime frame Inclusion of children: 1st of June 2019 to 31st of May 2021 Analysis of samples (RNA sequencing): 1st of June 2021 - 1st of December 2021\n\nPerspective\n\nThe study will create a base for a randomised trial regarding implementation of RNA signature versus normal procedure in handling febrile children with cancer. This can lead to the development of a targeted RNA-expression analytical platform that can prevent unnecessary antibiotic treatment in the majority of children with febrile neutropenia. This will reduce hospital admissions, side effects, antimicrobial resistance and improve quality of life during cancer treatment. The results can be extrapolated to the adult patients with cancer, who are often treated with prophylactic antibiotics, which complicate finding the infectious agent. Additionally, the test may be applied in other immunosuppressed children with infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with cancer and fever admitted to the Pediatric Oncology Departments throughout Denmark.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with cancer and fever. Fever defined as temperature above 38.5 °C measured once, or 38.0-38.5 °C for ≥ 1 hour.\n\nExclusion Criteria:\n\nThe children can be excluded if they turn out to have a different diagnosis than expected or if it is not possible to draw the blood tests.'}, 'identificationModule': {'nctId': 'NCT04669418', 'briefTitle': 'Host RNA Signature in Children With Cancer and Infection', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Host RNA Signature to Discriminate Bacterial From Viral Infection and Non-specific Inflammation in Children With Cancer', 'orgStudyIdInfo': {'id': 'H-2-2010-002_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': '70 children with cancer and a positive blood culture.', 'interventionNames': ['Diagnostic Test: RNA expression signature']}, {'label': 'Group 2', 'description': '50 children with cancer and no positive blood culture.', 'interventionNames': ['Diagnostic Test: RNA expression signature']}], 'interventions': [{'name': 'RNA expression signature', 'type': 'DIAGNOSTIC_TEST', 'description': 'Whole transcriptome profiling using RNA sequencing', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Pediatrics, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Pediatric Oncology, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Center for Genomic Medicine', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of pediatric and adolescent medicine, Rigshospitalet (Copenhagen University Hospital)', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': "Department of Pediatrics, The H.C. Andersen's Children's hospital", 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Lotte M. Smedegaard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ph.d.-student'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Børnecancerfonden', 'class': 'OTHER'}, {'name': 'Lundbeck Foundation', 'class': 'OTHER'}, {'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Lotte Møller Smedegaard', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}