Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-25 @ 7:13 PM
Study NCT ID:
NCT06296732
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009447', 'term': 'Neuroblastoma'}, {'id': 'D005729', 'term': 'Ganglioneuroma'}, {'id': 'D018305', 'term': 'Ganglioneuroblastoma'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2031-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-02-29', 'studyFirstSubmitQcDate': '2024-02-29', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of surgery intervention', 'timeFrame': 'Intraoperative', 'description': 'Pilot difficulty scoring system for laparoscopic surgery in abdominal neuroblastoma'}], 'secondaryOutcomes': [{'measure': 'The influence of surgical risk factors', 'timeFrame': 'Intraoperative and 30 days postoperative', 'description': 'The influence of surgical risk factors (see supplementary material) on the surgery results (see supplementary material) and the course of the postoperative period.'}, {'measure': 'Cases of conversion from laparoscopic to cavity access', 'timeFrame': 'Intraoperative'}, {'measure': "Comparison of surgeon's visual assessment of the tumor resection", 'timeFrame': '5 days postoperative', 'description': "Comparison of surgeon's visual assessment of the tumor resection completeness with data from abdominal contrast-enhanced CT, performed in the first 5 days after surgery."}, {'measure': '1-, 3-, 5-years local recurrence-free survival', 'timeFrame': 'up to 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neuroblastoma', 'Ganglioneuroma', 'Ganglioneuroblastoma', 'Laparoscopic surgery', 'Minimally-Invasive surgery', 'IDRF - image-defined risk factors', 'Risk factors', 'Difficulty scoring system', 'Complete resection'], 'conditions': ['Neuroblastoma', 'Ganglioneuroma', 'Ganglioneuroblastoma']}, 'descriptionModule': {'briefSummary': 'Surgery plays significant role in treatment of neurogenic tumors, both for benign ganglioneuroma and for high risk neuroblastoma. The world literature has accumulated large experience in laparoscopic surgery for abdominal neuroblastoma. The presence of IDRF (image-defined risk factors) and tumor size (\\>4-7 cm) are considered as common contraindications for minimally invasive surgery in neuroblastoma. However, the recent studies have shown that presence of IDRF is not an absolute contraindication for laparoscopic surgery. This open-label, nonrandomized, observational, phase III evaluates role and weight of different surgical risk factors (including IDRF, tumor size, tumor localization, tumor volume/patient height ratio, previous open surgical procedures, previous chemotherapy etc.) in the laparoscopic neuroblastoma resections. The aim of this study is to create novel risk factors scoring system for laparoscopic surgery in abdominal neuroblastoma.', 'detailedDescription': "After signing informed consent and surgical risk factors assessment (see Study Documents), eligible patients received surgical treatment - laparoscopic neuroblastoma resection. Parameters to be assessed are: duration of surgery intervention, intraoperative complications, blood loss volume, cases and volume of blood transfusion, conversion from laparoscopic to cavity access, surgeon's visual assessment completeness of the tumor resection. During 5 postoperative days patients undergo contrast-enhanced abdominal computed tomography (CT) to control completeness of the tumor resection assessment. Postoperative complications during 30 postoperative days to be accessed. In follow up period 1-, 3- and 5 years local recurrence-free survival to be accessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with abdominal neurogenic tumors in 0-18 years of age', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with neurogenic tumors meeting the criteria of groups I-III:\n\n Group I\n * low or moderate risk group according to pilot difficulty scoring system (less than 5 points, see supplementary material);\n * no IDRF;\n\n Group II:\n * low or moderate risk group according to pilot difficulty scoring system (less than 5 points);\n * patients with any number of IDRFs and without central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.\n\n Group III:\n * 2 and more IDRF + central tumor location and/or tumor extension across the midline;\n * 2 and more IDRF + tumor volume (cm3)/patient height (m) ratio = 28 or more;\n * 2 and more IDRF + 2 and more other risk factors according to pilot difficulty scoring system;\n * 1 IDRF + tumor extension across the midline + tumor volume (cm3)/patient height (m) ratio = 28 or more.\n2. Age from 0 to 18 years.\n3. Preoperative imaging (abdominal contrast-enhanced computed tomography (CT), performed no later than 14 days before the planned surgery).\n4. Indications for surgery based on the decision of multidisciplinary experts board in centers- participants.\n5. Written voluntary informed consent of the patient and / or his legal representative.\n\nExclusion Criteria:\n\n1. 3 and more IDRF + central tumor location and/or tumor extension across the midline and/or tumor volume (cm3)/patient height (m) ratio = 28 or more.\n2. Severe concomitant pathology, increasing anesthesiologic and surgical risks, via the desicion of the research physician or conclusion by multidisciplinary team in centers- participants.\n3. Tumor volume does not technically allow to provide minimally-invasive surgery, based on the conclusion of multidisciplinary experts board team in centers- participants.\n4. Therapy strategy: observation\n\n \\-'}, 'identificationModule': {'nctId': 'NCT06296732', 'acronym': 'ANLAP-R', 'briefTitle': 'Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification', 'organization': {'class': 'OTHER', 'fullName': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology'}, 'officialTitle': 'Abdominal Neuroblastoma Laparoscopic Surgery Risk Factors Stratification', 'orgStudyIdInfo': {'id': 'NCPHOI-2024-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Duration of surgery intervention', 'type': 'PROCEDURE', 'description': 'Intraoperative- duration from the beginning of the skin incision to skin suture (min)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Dmitry m Akhaladze, MD, Doc', 'role': 'CONTACT', 'email': 'd.g.akhaladze@gmail.com', 'phone': '+7 (905) 587-89-92,'}], 'facility': 'Research Institute of Pediatric Hematology, Oncology and Immunology', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Dmitry Akhaladze, MD, Doc', 'role': 'CONTACT', 'email': 'd.g.akhaladze@gmail.com', 'phone': '+7 (905) 587-89-92'}, {'name': 'Elena Smirnova', 'role': 'CONTACT', 'email': 'lena.smirnova@fccho-moscow.ru', 'phone': '+7(985)130-61-03'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal Research Institute of Pediatric Hematology, Oncology and Immunology', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center, Kazakhstan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}