Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 11:07 PM
Study NCT ID:
NCT06070259
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insights Into Participating in Studies for Bone Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-30', 'size': 72599, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-30T07:45', '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': '2024-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-30', 'studyFirstSubmitDate': '2023-09-30', 'studyFirstSubmitQcDate': '2023-09-30', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a bone cancer clinical research.', 'timeFrame': '3 months'}, {'measure': 'Number of bone cancer study participants who remain in clinical study until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bone Cancer'], 'conditions': ['Bone Cancer']}, 'referencesModule': {'references': [{'pmid': '35431084', 'type': 'BACKGROUND', 'citation': 'Ventura C, Nunez SV, Goncalves A, Abreu C, Costa L. Bone Health in Metastatic Cancer. Semin Oncol Nurs. 2022 Apr;38(2):151278. doi: 10.1016/j.soncn.2022.151278. Epub 2022 Apr 15.'}, {'pmid': '27006430', 'type': 'BACKGROUND', 'citation': 'Porta-Sales J, Garzon-Rodriguez C, Llorens-Torrome S, Brunelli C, Pigni A, Caraceni A. Evidence on the analgesic role of bisphosphonates and denosumab in the treatment of pain due to bone metastases: A systematic review within the European Association for Palliative Care guidelines project. Palliat Med. 2017 Jan;31(1):5-25. doi: 10.1177/0269216316639793. Epub 2016 Jul 10.'}, {'pmid': '19038965', 'type': 'BACKGROUND', 'citation': 'Niiyama Y, Kawamata T, Yamamoto J, Furuse S, Namiki A. SB366791, a TRPV1 antagonist, potentiates analgesic effects of systemic morphine in a murine model of bone cancer pain. Br J Anaesth. 2009 Feb;102(2):251-8. doi: 10.1093/bja/aen347. Epub 2008 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Clinical studies, with a distinct focus on bone cancer, play a crucial role in evaluating the safety and effectiveness of novel treatments for this disease. These trials serve as instrumental means to determine whether new medications surpass conventional therapies, providing substantial evidence for their broader adoption.\n\nThe primary objective is to meticulously scrutinize trial completion rates and voluntary withdrawals within this specific patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Bone cancer patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Diagnosis of bone cancer\n* No prior treatment for bone cancer\n\nExclusion Criteria:\n\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Enrolled in another research study\n* Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT06070259', 'briefTitle': 'Insights Into Participating in Studies for Bone Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Examining Patient Involvement Patterns and Trends in Participation in Bone Cancer Clinical Trials', 'orgStudyIdInfo': {'id': '72278769'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], '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'}}}}