Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05796258
Status:
COMPLETED
Last Update Posted:
2024-12-05
First Post:
2023-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue is routinely obtained after the surgical removal of the tumor tissue (primary or metastatic).\n\nPart of the tissue will be immediately processed for RNA extraction, the rest of the tissue is processed for conventional histology/IHC analysis and stored in the institutional tissue biobank.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2023-03-16', 'studyFirstSubmitQcDate': '2023-03-31', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of NTRK fusions in thyroid cancer', 'timeFrame': 'from 01-Jan-2022 to 31-Dec-2023', 'description': 'To assess the frequency of NTRK fusions in histological sample of tumors by patients affected by thyroid cancer, assessed as the number of tumor harboring NTRK fusion on the total of tumor analized'}], 'secondaryOutcomes': [{'measure': 'Assesment of the ability of Immunohistochemistry to identify for NTRK fusion', 'timeFrame': 'from 01-Jan-2022 to 31-Dec-2023', 'description': 'To assess the ability of Immunohistochemistry to detect NTRK fusion on histological sample (using NGS as comparator)'}, {'measure': 'Assesment of the ability of real time PCR to identify for NTRK fusion', 'timeFrame': 'from 01-Jan-2022 to 31-Dec-2023', 'description': 'To assess the ability of real time PCR to detect NTRK fusion on histological sample (using NGS as comparator)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ntrk fusion'], 'conditions': ['Thyroid Cancer']}, 'descriptionModule': {'briefSummary': 'This multi-center study aims at NTRK fusion testing of all patients with advanced thyroid cancer (any histotype and regardless of stage). The primary objective of this study is to assess the frequency of NTRK fusions in thyroid cancer. The secondary objective of this study is to develop an effective tool (testing) strategy for the detection of NTRK fusions in thyroid tumors, comparing the diagnostic tecniques available (IHC, real-time PCR and NGS).', 'detailedDescription': 'Thyroid cancer is the most common neoplasm of the endocrine system. Most thyroid carcinomas originate from the follicular epithelium and are distinguished in differentiated forms (DTC): papillary (PTC) and follicular (FTC) carcinomas. Both have a favorable prognosis and account for approximately 80% and 10% of all thyroid neoplasms, respectively. The undifferentiated form represented by the anaplastic thyroid carcinoma (ATC) is less frequent (about 2%) and represents one of the most aggressive human tumors with a survival that rarely exceeds 6-12 months. Medullary thyroid carcinoma (MTC), deriving from parafollicular C cells, is relatively rare (approximately 5%) and is associated with an intermediate prognosis between differentiated and poorly differentiated forms.\n\nAs to the prevalence of NTRK lesions, many authoritative papers and reviews claim very high (up to 75%) NTRK fusion frequencies, particularly in the common PTC. However, an extensive PubMed analysis back to year 1990 does not provide convincing support for this claim.Several techniques for NTRK fusion diagnosis exist, including pan-Trk IHC, FISH, reverse transcription PCR, DNA-based next-generation sequencing (NGS), and RNA-based NGS. Each of these assays has unique features, advantages, and limitations, and familiarity with these assays is critical to appropriately screen for NTRK fusions.\n\nThe aim of this study is to determine the frequency of NTRK fusions in advanced thyroid cancer patients and to compare the diagnostic tecniques available (IHC, real-time PCR and NGS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by advanced thyroid cancer (any histotype)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of advanced thyroid cancer (any histotype)\n* Informed consent.\n\nExclusion Criteria:\n\n* Patients with thyroid neoplasms without appropriate material for subsequent immunohistochemical and molecular studies;\n* Patients with non-advanced thyroid cancer'}, 'identificationModule': {'nctId': 'NCT05796258', 'acronym': 'NTRK', 'briefTitle': 'Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'A Multi-institutional Effort With a Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer', 'orgStudyIdInfo': {'id': 'RS1445/20(2421)'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NTRK fusion assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'To evaluate NTRK fusion presence by MCG, Immunohistochemistry or NGS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'Regina Elena National Cancer Institute', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Marialuisa Appetecchia, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regina Elena Cancer Institute'}]}, 'ipdSharingStatementModule': {'url': 'http://garr.it', 'infoTypes': ['STUDY_PROTOCOL', 'ANALYTIC_CODE'], 'timeFrame': 'After study end', 'ipdSharing': 'YES', 'description': 'Raw data will be published in open access databases', 'accessCriteria': 'open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, {'name': 'Bambino Gesù Hospital and Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marialuisa Appetecchia', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}