Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-02 @ 9:27 AM
Study NCT ID:
NCT07005869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2025-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brachial Plexus Tumors; Pathological Types and Surgical Approaches: Multi Center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1-motor power and sensory improvment', 'timeFrame': '2 years', 'description': 'Clinical:\n\nBetter outcome according to MRC Muscle Power Scale and Numeric Sensory Scale (NSS) The Medical Research Council (MRC) Muscle Power Scale is commonly used to assess motor power in patients. It ranges from 0 to 5, evaluating voluntary muscle contraction against gravity and resistance.\n\nThe Numeric Sensory Scale (NSS) is a simple and effective tool used to assess sensory function.\n\nIt is based on a numerical rating system from 0 to 10, where patients self-report their level of sensation. This scale is commonly used in neurological examinations to evaluate sensory deficits.'}, {'measure': 'Radiological out come', 'timeFrame': '2 years', 'description': 'Radiological :\n\nPostoperative MRI to detect the residual or recurrence of lesions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brachial Plexus Tumors']}, 'descriptionModule': {'briefSummary': 'Brachial plexus tumors, are rare, present significant challenges due to their intricate anatomical location and potential impact on upper limb function. These tumors arise from nerve sheath cells, including either benign schwannomas and neurofibromas, or as malignant peripheral nerve sheath tumors (MPNSTs), which require early diagnosis and intervention to improve patient outcomes (1). Surgical resection remains the primary treatment modality, aiming to alleviate symptoms and prevent further neurological compromise.', 'detailedDescription': "Brachial plexus tumors, are rare, present significant challenges due to their intricate anatomical location and potential impact on upper limb function. These tumors arise from nerve sheath cells, including either benign schwannomas and neurofibromas, or as malignant peripheral nerve sheath tumors (MPNSTs), which require early diagnosis and intervention to improve patient outcomes (1). Surgical resection remains the primary treatment modality, aiming to alleviate symptoms and prevent further neurological compromise.\n\nThe choice of surgical approach is influenced by the tumor's size, location, and relationship with surrounding neurovascular structures. Anterior approaches, including supraclavicular and infraclavicular incisions, provide excellent exposure for lesions in the upper and middle parts of the plexus, whereas posterior approaches are preferred for deep-seated or retroclavicular tumors (2). Intraoperative neurophysiological monitoring (IONM) has significantly improved surgical precision, reducing the risk of postoperative deficit .\n\nAdvancements in microsurgical techniques, such as nerve grafting and nerve transfers, have improved functional recovery in patients undergoing brachial plexus tumor resection. Early intervention and meticulous dissection help preserve nerve function and minimize postoperative deficits (3). Minimally invasive techniques, including endoscopic and robotic-assisted approaches, are being explored to reduce morbidity and improve surgical precision (4).\n\nDespite progress in surgical management, challenges remain, particularly in cases of malignant tumors where complete resection may not be feasible. Adjuvant therapies, including radiation and chemotherapy, are increasingly utilized for malignant brachial plexus tumors to enhance local control and reduce recurrence rates (5). Long-term follow-up and rehabilitation play a crucial role in optimizing functional recovery, emphasizing the need for a multidisciplinary approach (6).\n\nThis review aims to analyze the indications, techniques, and outcomes of different surgical approaches for brachial plexus tumors, providing insights into optimizing patient outcomes while minimizing surgical morbidity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n.Patients diagnosed with brachial plexus tumors confirmed through imaging\n\n.Age of Patients: Any age .\n\n.patients who are fit for surgery .\n\nExclusion Criteria:\n\n. Patients with non-tumorous brachial plexus pathologies (e.g., trauma, inflammation).\n\n.Patients with incomplete medical records or lost follow-up data.\n\n.Patients with recurrent tumors previously treated.\n\n.Patients who are unfit for surgery.'}, 'identificationModule': {'nctId': 'NCT07005869', 'briefTitle': 'Brachial Plexus Tumors; Pathological Types and Surgical Approaches: Multi Center Experience', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Brachial Plexus Tumors; Pathological Types and Surgical Approaches: Multi Center Experience', 'orgStudyIdInfo': {'id': 'Brachial plexus Tumors'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'brachial plexus tumors patients', 'description': 'patients who has brachial plexus tumors', 'interventionNames': ['Procedure: brachial plexus tumors excision']}], 'interventions': [{'name': 'brachial plexus tumors excision', 'type': 'PROCEDURE', 'description': 'excision of brachial plexus tumors', 'armGroupLabels': ['brachial plexus tumors patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fadwa Ah ahmed, master', 'role': 'CONTACT', 'email': 'fadwa.ahmed5@gmail.com', 'phone': '0201002673946'}], 'overallOfficials': [{'name': 'Mohamed Ab khallaf, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Fadwa Ahmwd Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}