Leiomyosarcoma Clinical Trial
Official title:
An In Depth Study Investigating The Experiences of Patients In Leiomyosarcoma Clinical Trials
| NCT number | NCT05548179 |
| Other study ID # | 87688730 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2023 |
| Est. completion date | October 2025 |
Clinical study participation has historically been heavily biased toward specific demographics. Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal. People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | October 2025 |
| Est. primary completion date | October 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients who decide to enroll in an leiomyosarcoma clinical trial | 3 months | ||
| Primary | Rate of patients who remain in leiomyosarcoma clinical trial to trial completion | 12 months |
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