Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 6:14 AM
Study NCT ID:
NCT05869994
Status:
WITHDRAWN
Last Update Posted:
2024-07-05
First Post:
2023-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Tumor specimens from patients with sarcoma who are scheduled for elective surgery.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Inactive study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antitumor activity', 'timeFrame': '1 month', 'description': "Inhibition of autologous cancer cell growth in vitro by autologous natural killer cells using an automated cell counter. For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoma']}, 'referencesModule': {'references': [{'pmid': '26513416', 'type': 'BACKGROUND', 'citation': 'Monette A, Ceccaldi C, Assaad E, Lerouge S, Lapointe R. Chitosan thermogels for local expansion and delivery of tumor-specific T lymphocytes towards enhanced cancer immunotherapies. Biomaterials. 2016 Jan;75:237-249. doi: 10.1016/j.biomaterials.2015.10.021. Epub 2015 Oct 9.'}]}, 'descriptionModule': {'briefSummary': "The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.", 'detailedDescription': "The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.\n\nStudy Design:\n\nOne hundred mL of blood will be collected in an EDTA container and transported to the laboratory for in vitro isolation and expansion of NK cell cultures.\n\nTwo or three weeks later, 25 cu mm of the patient's own tumor will be collected in PBS and transported to the laboratory for co-culture with autologous expanded and enhanced NK cells.\n\nInclusion Criteria:\n\nIndividuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n* Male or Female ≥ 18 years of age\n* Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma\n* Patients who are already scheduled for surgery\n* Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee\n* Willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria: Patients who do not meet the inclusion criteria.\n\nMethodology:\n\nMale and female subjects \\> 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.\n\nStudy Duration:\n\nThe study is expected to take 24-30 months\n\nStatistical Analysis Plan For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate. Assuming the required statistical power of 0.9 with a significance level of 0.05 and effect size of 0.4, an equal sample size of at least 19 is suggested for each group: 1) Untreated, 2) CH-SCP, 3) Nk cells and 4) CH-SCP-NK-based hydrogel. Differences in mean tumor growth and survival rate between the control and experimental groups at each time point will be tested with independent ANOVA followed by Tukey's HSD test as a post-hoc analysis where appropriate.\n\nBaseline Descriptive Statistics Demographics, age, ethnicity, subtypes of sarcoma, number of patients, patients with locally advanced or metastatic will be described using descriptive statistics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects \\> 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:\n\n * Male or Female ≥ 18 years of age\n * Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma\n * Patients who are already scheduled for surgery\n * Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee\n * Willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\nPatients who do not meet inclusion criteria.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT05869994', 'briefTitle': 'Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures', 'organization': {'class': 'OTHER', 'fullName': 'Sarcoma Oncology Research Center, LLC'}, 'officialTitle': 'Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures', 'orgStudyIdInfo': {'id': 'SOC-2205'}}, 'contactsLocationsModule': {'locations': [{'zip': '90403', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Sarcoma Oncology Research Center', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Erlinda M Gordon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sarcoma Oncology Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sarcoma Oncology Research Center, LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}