Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT04755205
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2021-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Natural History Study of Children and Adults With Olfactory Neuroblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018304', 'term': 'Esthesioneuroblastoma, Olfactory'}], 'ancestors': [{'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D018241', 'term': 'Neuroectodermal Tumors, Primitive, Peripheral'}, {'id': 'D018242', 'term': 'Neuroectodermal Tumors, Primitive'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D020431', 'term': 'Olfactory Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 525}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-05', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-27', 'studyFirstSubmitDate': '2021-02-13', 'studyFirstSubmitQcDate': '2021-02-13', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize the natural history of ONB', 'timeFrame': 'duration of study', 'description': 'To characterize the natural history of ONB including clinical presentation, family history, patterns of disease progression, response to current treatment methods, disease recurrence, and overall survival.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esthesioneuroblastoma', 'nasal cavity tumor', 'pediatric onb', 'adult onb', 'Natural History'], 'conditions': ['Olfactory Neuroblastoma', 'Esthesioneuroblastoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2021-C-0009.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nOlfactory neuroblastoma (ONB) is a rare cancer. It grows from tissue in the upper part of the nose cavity, related to the sense of smell and can affect a person s sense of smell. Researchers want to better understand the health problems of people with ONB. This may help them design better treatment and supportive care studies.\n\nObjective:\n\nTo better understand ONB-the course of the disease, tumor characteristics, response to treatments, and management of the treatment.\n\nEligibility:\n\nPeople ages 3 years and older who have ONB. They must enroll in NIH studies #19-C-0016 and #18-DC-0051.\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants do not have to visit NIH.\n\nParticipants will give a blood sample. They will complete surveys to assess their emotional and physical wellbeing and needs. Leftover tissue from biopsies and surgeries will be collected.\n\nParticipants will take smell tests. They will smell items and answer questions about them.\n\nParticipants may take taste tests. They will get plastic taste strips that they will move around their mouth to determine the taste.\n\nParticipants may have a physical exam. Their performance status may be assessed.\n\nParticipants may give blood, saliva, urine, and nasal secretion samples.\n\nParticipants may have computed tomography and/or magnetic resonance imaging scans.\n\nParticipants may have one or more tumor biopsies.\n\nParticipants will talk to the research team about the results of their medical record/tests evaluation. The team will recommend how to best manage and treat their disease.\n\nParticipants may give samples and complete surveys every 12 months. Their medical records will be reviewed every year. They will be monitored for the rest of their life.', 'detailedDescription': 'Background:\n\nOlfactory neuroblastoma (ONB), also known as esthesioneuroblastoma, is a malignant tumor of the nasal cavity believed to arise from the olfactory epithelium. ONB is rare, with a reported incidence of 0.4 per million (approximately 300 cases per year in the United States).\n\nONB most frequently arises in adults aged 20-60 years. Pediatric ONB is particularly rare, with only small case series or multi-institutional studies reported. However, a Surveillance Epidemiology and End Results (SEER) study of 47 pediatric patients with intranasal malignancy reported ONB as the most frequent pediatric intranasal malignancy (28%).\n\nDue to the location of ONB in the sinonasal tract and anterior skull base, the presenting symptoms are often non-specific, including nasal obstruction and epistaxis, thus patients often present at advanced stages. Furthermore, ONB has a propensity for local invasion and relatively high rates of distant spread most commonly to the neck, lungs, and bones.\n\nClinical management in adults is generally surgical with adjuvant radiation.\n\nThe natural history of pediatric and adult ONB is incompletely understood, and treatment options for recurrent or metastatic ONB are limited. The planned natural history study as part of the NCI POB Rare Tumor Patient Engagement Network (RTPEN) will allow for comprehensive evaluation and recommendations to these patients while longitudinally collecting clinical, epidemiologic, and biological data.\n\nObjective:\n\nTo characterize the natural history of ONB including clinical presentation, family history, patterns of disease progression, response to current treatment methods, disease recurrence, and overall survival\n\nEligibility:\n\nParticipants of age \\>= 3 years old with histologically documented ONB.\n\nSubjects must also enroll on NIDCD Protocol 18-DC-0051.\n\nDesign:\n\nThis protocol is intended to characterize the natural history of olfactory neuroblastoma.\n\nParticipants will undergo a comprehensive study entry evaluation including acquisition of imaging of tumor sites.\n\nMedical histories will be documented, and participants followed throughout the course of their disease, with particular attention to patterns of disease recurrence and progression, response to therapies, duration of responses, and patient reported outcomes. Specimens will be obtained longitudinally, when feasible, and tumor growth rates will also be assessed throughout the course of the disease, when feasible.\n\nBlood and tumor samples may be obtained at study entry and while on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with olfactory neuroblastoma.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n* Subjects must also enroll on NCI Protocol 18-DC-0051: "Biospecimen Procurement for NIDCD Clinical Protocols".\n* Subjects with histologically documented olfactory neuroblastoma.\n* Age \\>= 3 years old.\n* Ability of subject to understand and the willingness to sign a written consent document\n\nEXCLUSION CRITERIA:\n\nPregnant women are excluded from this study because of more than minimal risk activities (imaging studies with contrast, biopsies) pertaining to enrollment.'}, 'identificationModule': {'nctId': 'NCT04755205', 'briefTitle': 'A Natural History Study of Children and Adults With Olfactory Neuroblastoma', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Natural History Study of Children and Adults With Olfactory Neuroblastoma', 'orgStudyIdInfo': {'id': '210009'}, 'secondaryIdInfos': [{'id': '21-C-0009'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'Subjects with confirmed olfactory neuroblastoma.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'For more information at the NIH Clinical Center contact National Cancer Institute Referral Office', 'role': 'CONTACT', 'phone': '888-624-1937'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Marissa B Mallek, R.N.', 'role': 'CONTACT', 'email': 'marissa.mallek@nih.gov', 'phone': '(240) 760-7498'}, {'name': 'Charalampos Floudas, M.D.', 'role': 'CONTACT', 'email': 'charalampos.floudas@nih.gov', 'phone': '(240) 858-3032'}], 'overallOfficials': [{'name': 'Charalampos Floudas, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.', 'ipdSharing': 'YES', 'description': 'All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@@@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.', 'accessCriteria': 'Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. @@@@@@@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}