Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 11:23 PM
Study NCT ID:
NCT06304194
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-07-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average sample delivery time and % of accepted sample', 'timeFrame': 'After 5 year from the beginning of the study', 'description': 'average sample delivery time and % of samples accepted within 48 ±12 hours of collection out of total samples sent'}, {'measure': 'Appropriateness sample labelling', 'timeFrame': 'After 5 year from the beginning of the study', 'description': '% samples correctly labelled according to IATA criteria out of total samples accepted within 48 hours'}, {'measure': 'Percentage of sample suitable for RNA extraction', 'timeFrame': 'After 5 year from the beginning of the study', 'description': '% samples suitable for RNA extraction out of total samples intended for RNA analysis'}, {'measure': 'Quantity and quality of extracted material.', 'timeFrame': 'After 5 year from the beginning of the study', 'description': '% of samples valid for analysis in terms of quantity of extracted material (25 ng/ul for cfDNA, 25 ng per amplicon for genomic DNA, 100 ng tot for NGS) and quality, assessed as A260/280 ratio analysis (1.8-2 per DNA).'}, {'measure': 'Research report production time', 'timeFrame': 'After 5 year from the beginning of the study', 'description': 'research report production time (from 2 weeks for known mutation analysis to 6 months for NGS).'}], 'secondaryOutcomes': [{'measure': 'Genetic variants', 'timeFrame': 'After 5 year from the beginning of the study', 'description': '% variants validated with NGS and Sanger or in two independent experiments out of the total number of variants identified'}, {'measure': 'Completed patient cards', 'timeFrame': 'After 5 year from the beginning of the study', 'description': '% of completed patient cards out of total patient cards of registered patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oncologic Disease', 'Hematologic Diseases']}, 'descriptionModule': {'briefSummary': 'Currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the CROP centers, is done through centralization of biological samples at reference laboratories outside the Tuscany Region.\n\nIn order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the CROP centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the IRCCS AOU Meyer Oncohematology Laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future.\n\nThis will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. The goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnostic suspicion of oncologic, hematologic or onco-immunologic disease\n* Suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease\n* Availability of biological material\n* Signature of informed consent\n* Age between 0 and 30 years\n\nExclusion Criteria:\n\n* Failure to sign the consent\n* Insufficiency of biological material for analysis\n* Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior."}, 'identificationModule': {'nctId': 'NCT06304194', 'briefTitle': 'Molecular Characterizazion and Biological Samples Centralisation of Patients Affected by Oncoematolofic Pathology', 'organization': {'class': 'OTHER', 'fullName': "Meyer Children's Hospital IRCCS"}, 'officialTitle': 'Pilot Study to Assess the Feasibility of Centralizing Biological Samples at Onset and Relapse of Patients Referred to CROP Centers for Molecular Characterization of Oncohematologic Pathology', 'orgStudyIdInfo': {'id': 'BIOMARC_ONCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with suspected diagnostic onco-hematologic/immunologic disease', 'description': 'All patients with suspected diagnostic onco-hematologic, onco-immunologic, and hematologic disease at onset or relapse.\n\nPatients undergo several procedures to complete the diagnostic process and eventually the staging of the disease', 'interventionNames': ['Other: Analysis of biological samples']}], 'interventions': [{'name': 'Analysis of biological samples', 'type': 'OTHER', 'description': 'The collected biological sample will be isolated and the specific nucleic acid (DNA/RNA/cfDNA) extracted for molecular analysis for understanding the reproducibility of the analysis and thus the feasibility of centralization:\n\n* hot spot on DNa (ddPCR/Sanger)\n* fusion genes on RNA (target resequencing)\n* Known mutation analysis by liquid biopsy (cfDNA) for somatic mutations with a mutation frequency of less than 10%\n* Tumor type-associated gene sequence analysis by Sanger sequencing and NGS', 'armGroupLabels': ['Patients with suspected diagnostic onco-hematologic/immunologic disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marinella Veltroni', 'role': 'CONTACT', 'email': 'marinella.veltroni@meyer.it'}], 'facility': "Meyer Children's Hospital IRCCS", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriella Casazza', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Pisana', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Siena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Grosso', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}], 'centralContacts': [{'name': 'Marinella Veltroni', 'role': 'CONTACT', 'email': 'marinella.veltroni@meyer.it', 'phone': '0555662606'}], 'overallOfficials': [{'name': 'Marinella Veltroni', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Meyer Children's Hospital IRCCS"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Meyer Children's Hospital IRCCS", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marinella Veltroni', 'investigatorAffiliation': "Meyer Children's Hospital IRCCS"}}}}