Studies
| Study First Submitted Date | 2022-09-16 |
| Study First Posted Date | 2022-09-21 |
| Last Update Posted Date | 2023-03-06 |
| Start Month Year | October 2023 |
| Primary Completion Month Year | October 2024 |
| Verification Month Year | September 2022 |
| Verification Date | 2022-09-30 |
| Last Update Posted Date | 2023-03-06 |
Conditions
| Sequence: | 52071642 |
| Name | Leiomyosarcoma |
| Downcase Name | leiomyosarcoma |
Id Information
| Sequence: | 40079515 |
| Id Source | org_study_id |
| Id Value | 87688730 |
Keywords
| Sequence: | 79704454 |
| Name | leiomyosarcoma |
| Downcase Name | leiomyosarcoma |
Design Outcomes
| Sequence: | 177036714 | Sequence: | 177036715 |
| Outcome Type | primary | Outcome Type | primary |
| Measure | Number of patients who decide to enroll in an leiomyosarcoma clinical trial | Measure | Rate of patients who remain in leiomyosarcoma clinical trial to trial completion |
| Time Frame | 3 months | Time Frame | 12 months |
Browse Conditions
| Sequence: | 193089814 | Sequence: | 193089815 | Sequence: | 193089819 | Sequence: | 193089816 | Sequence: | 193089817 | Sequence: | 193089818 |
| Mesh Term | Leiomyosarcoma | Mesh Term | Neoplasms, Muscle Tissue | Mesh Term | Sarcoma | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
| Downcase Mesh Term | leiomyosarcoma | Downcase Mesh Term | neoplasms, muscle tissue | Downcase Mesh Term | sarcoma | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48226753 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Power Life Sciences Inc. |
Overall Officials
| Sequence: | 29227061 |
| Role | Study Director |
| Name | Michael B Gill |
| Affiliation | Power Life Sciences Inc. |
Central Contacts
| Sequence: | 11987998 |
| Contact Type | primary |
| Name | Michael B Gill |
| Phone | 4159004227 |
| bask@withpower.com | |
| Role | Contact |
Eligibilities
| Sequence: | 30707249 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization. |
| Criteria | Inclusion Criteria: Patient has self-identified as planning to enroll in an interventional clinical trial Patient has been diagnosed with leiomyosarcoma Patient is a minimum of 18 years or older Exclusion Criteria: Patient does not understand, sign, and return consent form Inability to perform regular electronic reporting Patient is pregnant ECOG score of 4 |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253929058 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
Designs
| Sequence: | 30453852 |
| Observational Model | Case-Crossover |
| Time Perspective | Prospective |
Provided Documents
| Sequence: | 2575051 |
| Document Type | Informed Consent Form |
| Has Protocol | False |
| Has Icf | True |
| Has Sap | False |
| Document Date | 2022-09-16 |
| Url | https://ClinicalTrials.gov/ProvidedDocs/79/NCT05548179/ICF_000.pdf |
Responsible Parties
| Sequence: | 28820322 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51966437 | Sequence: | 51966438 | Sequence: | 51966439 |
| Pmid | 34298376 | Pmid | 24093170 | Pmid | 35275323 |
| Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | Kantidakis G, Litiere S, Neven A, Vinches M, Judson I, Schoffski P, Wardelmann E, Stacchiotti S, D'Ambrosio L, Marreaud S, van der Graaf WTA, Kasper B, Fiocco M, Gelderblom H. Efficacy thresholds for clinical trials with advanced or metastatic leiomyosarcoma patients: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group meta-analysis based on a literature review for soft-tissue sarcomas. Eur J Cancer. 2021 Sep;154:253-268. doi: 10.1016/j.ejca.2021.06.025. Epub 2021 Jul 20. | Citation | Serrano C, George S. Leiomyosarcoma. Hematol Oncol Clin North Am. 2013 Oct;27(5):957-74. doi: 10.1016/j.hoc.2013.07.002. Epub 2013 Aug 26. | Citation | Kasper B, D'Ambrosio L, Davis EJ, Ingham M, Broto JM, Trent JC, van Houdt WJ, Van Tine BA. What Clinical Trials Are Needed for Treatment of Leiomyosarcoma Curr Treat Options Oncol. 2022 Mar;23(3):439-449. doi: 10.1007/s11864-021-00928-y. Epub 2022 Mar 11. |