Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-27 @ 3:10 AM
Study NCT ID:
NCT05819593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-19
First Post:
2023-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Trends in Anaplastic Thyroid Cancer Patients' Clinical Study Experiences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-06', 'size': 74030, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-04-06T08:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-06', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-06', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of anaplastic thyroid cancer patients who decide to enroll in a clinical study', 'timeFrame': '3 months'}, {'measure': 'Rate of anaplastic thyroid cancer patients who remain in a clinical study to completion', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anaplastic thyroid cancer'], 'conditions': ['Anaplastic Thyroid Cancer']}, 'referencesModule': {'references': [{'pmid': '32751138', 'type': 'BACKGROUND', 'citation': 'Al-Jundi M, Thakur S, Gubbi S, Klubo-Gwiezdzinska J. Novel Targeted Therapies for Metastatic Thyroid Cancer-A Comprehensive Review. Cancers (Basel). 2020 Jul 29;12(8):2104. doi: 10.3390/cancers12082104.'}, {'pmid': '30352606', 'type': 'BACKGROUND', 'citation': 'Saini S, Tulla K, Maker AV, Burman KD, Prabhakar BS. Therapeutic advances in anaplastic thyroid cancer: a current perspective. Mol Cancer. 2018 Oct 23;17(1):154. doi: 10.1186/s12943-018-0903-0.'}, {'pmid': '31277524', 'type': 'BACKGROUND', 'citation': 'Ljubas J, Ovesen T, Rusan M. A Systematic Review of Phase II Targeted Therapy Clinical Trials in Anaplastic Thyroid Cancer. Cancers (Basel). 2019 Jul 4;11(7):943. doi: 10.3390/cancers11070943.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative.\n\nThe goal is to identify the obstacles and challenges that prevent participation in anaplastic thyroid cancer clinical research, as well as the reasons for withdrawal or discontinuation.\n\nInsights gained from this study will ultimately benefit those with anaplastic thyroid cancer who may be invited to participate in clinical research in the years to come.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with anaplastic thyroid cancer who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with anaplastic thyroid cancer\n* Willing to comply with all study related procedures and assessments\n* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* No documented diagnosis of anaplastic thyroid cancer\n* Any serious and/or unstable pre-existing medical disorders\n* Pregnant or lactating woman'}, 'identificationModule': {'nctId': 'NCT05819593', 'briefTitle': "Evaluating Trends in Anaplastic Thyroid Cancer Patients' Clinical Study Experiences", 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'A Critical Analysis of Anaplastic Thyroid Clinical Trials: Perspectives From Patient Experiences', 'orgStudyIdInfo': {'id': '80865259'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}