Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-25 @ 8:51 PM
Study NCT ID:
NCT02910895
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2016-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A platform of Patient Derived Xenografts (PDX) of Soft Tissue Sarcomas of patients with sarcomas', 'timeFrame': '4 months', 'description': 'take rate'}, {'measure': 'The take-rate of fresh human PDX tumour material in nude mice.', 'timeFrame': '4 months', 'description': 'take rate'}, {'measure': 'A consistent system for further anti-sarcoma therapy (both RT and chemotherapy experiments)', 'timeFrame': '2 years after start of study', 'description': 'take rate'}, {'measure': 'A platform of 2D/3D cell cultures (organoids) of Soft Tissue Sarcomas.', 'timeFrame': '6 weeks', 'description': 'take rate'}, {'measure': 'A model for translational research', 'timeFrame': '2 years after start of study', 'description': 'take rate'}], 'secondaryOutcomes': [{'measure': 'The passage possibilities of human PDX tumour material by freezing, storing, thawing and re-inoculating in nude mice', 'timeFrame': '4 months after implantation of tumour material', 'description': 'take rate of continuous growth of implantation of tumor material'}, {'measure': 'Fractionation sensitivity on several STS subtypes in PDX.', 'timeFrame': '4 months', 'description': 'take rate'}, {'measure': 'To study the passage possibilities of 2D/3D cell cultures by freezing, storing and thawing', 'timeFrame': '1 month', 'description': 'take rate of continuous growth'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Soft Tissue Sarcoma', 'Xenograft Model', '2D/3D Cell Cultures']}, 'descriptionModule': {'briefSummary': 'Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease.\n\nThe current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosed (non-) metastatic intermediate to high grade STS\n* Local recurrences are allowed\n* Age ≥ 18 years\n* Able and willing to undergo tumour biopsies or tumour sampling during surgery\n* Localization of sarcoma enables safe biopsy or surgery\n* Written informed consent\n\nExclusion Criteria:\n\n* Known coagulation disorder and/or anticoagulant medication in as far it might interfere with a safe biopsy procedure (to the discretion of the treating physician and attending radiologist)\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the study'}, 'identificationModule': {'nctId': 'NCT02910895', 'acronym': 'SarcomaPDX', 'briefTitle': 'A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Development of a Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS): Protocol to Obtain Tumour Material From Patients With STS.', 'orgStudyIdInfo': {'id': 'N16STS'}, 'secondaryIdInfos': [{'id': 'NL58626.031.16', 'type': 'REGISTRY', 'domain': 'CCMO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single arm', 'description': 'single tumor biopsy', 'interventionNames': ['Other: tumor biopsy']}], 'interventions': [{'name': 'tumor biopsy', 'type': 'OTHER', 'description': 'biopsy', 'armGroupLabels': ['single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066CX', 'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rick Haas, MD, PhD', 'role': 'CONTACT', 'email': 'r.haas@nki.nl', 'phone': '+31 20 512 9111'}, {'name': 'Astrid Scholten, MD, PhD', 'role': 'CONTACT', 'email': 'a.scholten@nki.nl', 'phone': '+31 20 512 9111'}], 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'centralContacts': [{'name': 'Rick Haas, MD, PhD', 'role': 'CONTACT', 'email': 'r.haas@nki.nl', 'phone': '+31 20 512 9111'}, {'name': 'Astrid Scholten, MD, PhD', 'role': 'CONTACT', 'email': 'a.scholten@nki.nl', 'phone': '+31 20 512 9111'}], 'overallOfficials': [{'name': 'Rick Haas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Netherlands Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}