Studies
| Study First Submitted Date | 2022-09-06 |
| Study First Posted Date | 2022-09-10 |
| 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: | 52009231 |
| Name | Osteosarcoma |
| Downcase Name | osteosarcoma |
Id Information
| Sequence: | 40032081 |
| Id Source | org_study_id |
| Id Value | 83926159 |
Keywords
| Sequence: | 79609480 |
| Name | osteosarcoma |
| Downcase Name | osteosarcoma |
Design Outcomes
| Sequence: | 176812409 | Sequence: | 176812410 |
| Outcome Type | primary | Outcome Type | primary |
| Measure | Number of patients who decide to enroll in an osteosarcoma clinical trial | Measure | Rate of patients who remain in osteosarcoma clinical trial to trial completion |
| Time Frame | 3 months | Time Frame | 12 months |
Browse Conditions
| Sequence: | 192845684 | Sequence: | 192845678 | Sequence: | 192845679 | Sequence: | 192845680 | Sequence: | 192845681 | Sequence: | 192845682 | Sequence: | 192845683 |
| Mesh Term | Sarcoma | Mesh Term | Osteosarcoma | Mesh Term | Neoplasms, Bone Tissue | Mesh Term | Neoplasms, Connective Tissue | Mesh Term | Neoplasms, Connective and Soft Tissue | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms |
| Downcase Mesh Term | sarcoma | Downcase Mesh Term | osteosarcoma | Downcase Mesh Term | neoplasms, bone tissue | Downcase Mesh Term | neoplasms, connective tissue | Downcase Mesh Term | neoplasms, connective and soft tissue | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms |
| Mesh Type | mesh-ancestor | 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: | 48167996 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Power Life Sciences Inc. |
Overall Officials
| Sequence: | 29192407 |
| Role | Study Director |
| Name | Michael B Gill |
| Affiliation | Power Life Sciences Inc. |
Central Contacts
| Sequence: | 11972583 |
| Contact Type | primary |
| Name | Michael B Gill |
| Phone | 4159004227 |
| bask@withpower.com | |
| Role | Contact |
Eligibilities
| Sequence: | 30670427 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Population | Osteosarcoma patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization. |
| Criteria | Inclusion Criteria: Patient has been diagnosed with osteosarcoma Patient has self-identified as planning to enroll in an interventional clinical trial Patient is a minimum of 18 years or older Exclusion Criteria: ECOG score of 4 Patient is pregnant Inability to perform regular electronic reporting Patient does not understand, sign, and return consent form |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254295450 |
| 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: | 30417203 |
| Observational Model | Case-Crossover |
| Time Perspective | Prospective |
Provided Documents
| Sequence: | 2573325 |
| Document Type | Informed Consent Form |
| Has Protocol | False |
| Has Icf | True |
| Has Sap | False |
| Document Date | 2022-09-06 |
| Url | https://ClinicalTrials.gov/ProvidedDocs/83/NCT05535283/ICF_000.pdf |
Responsible Parties
| Sequence: | 28783714 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51897350 | Sequence: | 51897351 | Sequence: | 51897352 |
| Pmid | 18456784 | Pmid | 11925089 | Pmid | 19230551 |
| Reference Type | background | Reference Type | background | Reference Type | background |
| Citation | Bielack S, Carrle D, Jost L; ESMO Guidelines Working Group. Osteosarcoma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008 May;19 Suppl 2:ii94-6. doi: 10.1093/annonc/mdn102. No abstract available. | Citation | Wittig JC, Bickels J, Priebat D, Jelinek J, Kellar-Graney K, Shmookler B, Malawer MM. Osteosarcoma: a multidisciplinary approach to diagnosis and treatment. Am Fam Physician. 2002 Mar 15;65(6):1123-32. | Citation | Burns L, Perisoglou M. Clinical trials in osteosarcoma treatment: patients' perspective through art. Recent Results Cancer Res. 2009;179:345-61. doi: 10.1007/978-3-540-77960-5_22. |