Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 1:18 AM
Study NCT ID:
NCT04425434
Status:
RECRUITING
Last Update Posted:
2025-10-03
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Recommendations For The Treatment Of Children With A 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cases with retinoblastoma in each participating hospital.', 'timeFrame': '10 years', 'description': 'Evaluation of the number of cases registered .'}, {'measure': 'Number of cases with stage 2 disease', 'timeFrame': '10 years', 'description': 'Evaluation of the number of cases registered with stage 2 disease.'}, {'measure': 'Feasibility of these therapeutic recommendations in an African setting', 'timeFrame': '10 years', 'description': 'Evaluate the application of these therapeutic recommendations'}, {'measure': 'Evaluating the treatment given.', 'timeFrame': '10 years', 'description': 'Comparison of treatment given and recommended treatment.'}, {'measure': 'follow up', 'timeFrame': '10 years', 'description': 'analysis of the number of children alive or dead after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinoblastoma']}, 'descriptionModule': {'briefSummary': 'As the survival of children with retinoblastoma in high income countries is higher than 95% including the bilateral forms this study hopes to improve the outcome in low income countries in Africa by improving early diagnosis and early implementation of this protocol of therapeutic recommendations for treatment.', 'detailedDescription': 'In this study we will try to improve the outcome for children with stage II disease. It is hoped that we will be able to show that with early intervention correct early diagnosis the survival of these children is greatly improved. The collection of data in this observational study will allow us to show this improvement, by analysis of stage, treatment and outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all children presenting at participating units who can be treated', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral intraocular Retinoblastoma (RB)\n* Unilateral extraocular intraorbital (RB)\n* Bilateral intraocular (RB)\n* bilateral intraocular (RB) on one side and extraocular but intraorbital on the other side.\n\nExclusion Criteria:\n\n* Externalized tumor mass\n* massive extension to optic nerve up to optical channeltumor\n* intracranial extension leptomeninges\n* cerebral parenchyma\n* extension to regional lymph nodes and/or remote metastases.\n* cerebrospinal fluid involvement.\n* Trilateral RB\n* Incapacity to followed the whole treatement.'}, 'identificationModule': {'nctId': 'NCT04425434', 'acronym': 'GFARB12019', 'briefTitle': 'Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma', 'organization': {'class': 'OTHER', 'fullName': 'French Africa Pediatric Oncology Group'}, 'officialTitle': 'Therapeutic Recommendations For The Treatment Of Children With A Retinoblastoma', 'orgStudyIdInfo': {'id': 'GFAOP RB1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OBSERVATIONAL', 'type': 'OTHER', 'description': 'We will look at the outcome of the the children treated to see if the survival is improved when these therapeutic measures are followed.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03 BP 7022', 'city': 'Ouagadougou', 'status': 'RECRUITING', 'country': 'Burkina Faso', 'contacts': [{'name': 'BOUDA Dr Chantal, Dr', 'role': 'CONTACT', 'email': 'chantal.bouda@gfaop.org'}], 'facility': 'Hopital Yalgado Ouedraogo', 'geoPoint': {'lat': 12.36566, 'lon': -1.53388}}, {'city': 'Abidjan', 'status': 'RECRUITING', 'country': 'Côte d’Ivoire', 'contacts': [{'name': 'Line Dr COUITCHERE, DOCTOR', 'role': 'CONTACT', 'email': 'line.couitchere@gfaop.org'}], 'facility': 'CHU de Treichville à ABIDJAN', 'geoPoint': {'lat': 5.35444, 'lon': -4.00167}}, {'zip': 'BP 12 KIN XI', 'city': 'Kinshasa', 'state': 'Kinshasa City', 'status': 'RECRUITING', 'country': 'Democratic Republic of the Congo', 'contacts': [{'name': 'Aléine BUDIONGO, DR', 'role': 'CONTACT', 'email': 'albudiongo@gmail.com', 'phone': '+(243)99 81 53 133.'}], 'facility': 'CUK (Cliniques Universitaires de Kinshasa)', 'geoPoint': {'lat': -4.32758, 'lon': 15.31357}}, {'zip': 'BP 1825', 'city': 'Lubumbashi', 'status': 'RECRUITING', 'country': 'Democratic Republic of the Congo', 'contacts': [{'name': 'Robert LUKAMBA, DR', 'role': 'CONTACT', 'email': 'robertlukamba@yahoo.fr', 'phone': '00(243) 972 262 144'}], 'facility': 'Cliniques Universitaires de Lubumbashi (CUL)', 'geoPoint': {'lat': -11.66089, 'lon': 27.47938}}, {'zip': 'BP 4150', 'city': 'Antananarivo', 'state': 'Ampefiloha', 'status': 'RECRUITING', 'country': 'Madagascar', 'contacts': [{'name': 'Mbola RAKOTOMAHEFA, DR', 'role': 'CONTACT', 'email': 'mahefambola@yahoo.fr', 'phone': '(261) 33 05 055 66'}], 'facility': 'HJRA, Hôpital universitaire Joseph Ravoahangy Andrianavalona', 'geoPoint': {'lat': -18.91368, 'lon': 47.53613}}, {'city': 'Bamako', 'status': 'RECRUITING', 'country': 'Mali', 'contacts': [{'name': 'Boubacar TOGO, PROFESSEUR', 'role': 'CONTACT', 'email': 'boubacar.togo@gfaop.org', 'phone': '+223 66 74 29 04'}], 'facility': 'CHU Gabriel Touré (HGT)', 'geoPoint': {'lat': 12.60915, 'lon': -7.97522}}, {'zip': 'BP 3001', 'city': 'Dakar', 'status': 'RECRUITING', 'country': 'Senegal', 'contacts': [{'name': 'Fatou-Binetou DIAGNE AKONDE, DR', 'role': 'CONTACT', 'phone': '00(221)77 637 40 63'}], 'facility': 'Hôpital Aristide Le Dantec,', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'centralContacts': [{'name': 'KARIM Mr ASSANI, Dr.', 'role': 'CONTACT', 'email': 'drassanik@gmail.com', 'phone': '00243971359726'}, {'name': 'BRENDA Ms MALLON, MSc', 'role': 'CONTACT', 'email': 'brenda.mallon@gustaveroussy.fr', 'phone': '0033142115411'}], 'overallOfficials': [{'name': 'FOUSSEYNI Mr TRAORE, Dr;', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMCC AND GFAOP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Africa Pediatric Oncology Group', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}