Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT04451304
Status:
UNKNOWN
Last Update Posted:
2020-06-30
First Post:
2020-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'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': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2020-06-25', 'studyFirstSubmitQcDate': '2020-06-25', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiorespiratory autonomic reflexes incidence', 'timeFrame': 'from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)', 'description': 'To evaluate the incidence of cardiorespiratory autonomic reflexes during intra-arterial chemotherapy of the ophthalmic artery in a child cancer center.'}], 'secondaryOutcomes': [{'measure': 'Clinical background and autonomic reflexes occurence', 'timeFrame': 'from the admission of the patient in the operating room until the end of the procedure.', 'description': 'To evaluate the association between perioperative characteristics (both baseline and intraoperative characteristics) and the incidence of cardiorespiratory autonomic reflexes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retinoblastoma'], 'conditions': ['Retinoblastoma', 'Retinoblastoma Bilateral', 'Chemotherapy Effect']}, 'descriptionModule': {'briefSummary': 'Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children undergoing cancer treatment for unilateral or bilateral retinoblastoma at the Instituto de Oncologia Pediátrica da Universidade Federal de São Paulo - GRAACC, São Paulo - Brasil.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period\n* Informed consent form signed and dated by legal guardian and investigator\n* Informed assent form signed by the patient if appropriate\n\nExclusion Criteria:\n\n* Refusal of the patient or guardian to participate in the research project'}, 'identificationModule': {'nctId': 'NCT04451304', 'briefTitle': 'Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'CAAE 28598120.5.0000.5505'}}, 'contactsLocationsModule': {'locations': [{'zip': '04023-062', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Mariana F Lima, MD', 'role': 'CONTACT', 'email': 'marifonteslima@yahoo.com.br', 'phone': '+551150809236'}], 'facility': 'Federal University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Mariana F Lima, MD, PhD', 'role': 'CONTACT', 'email': 'marifonteslima@yahoo.com.br', 'phone': '+551150809236'}], 'overallOfficials': [{'name': 'Mariana F Lima, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of São Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mariana Fontes Lima Neville', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}