Rhabdomyosarcoma Clinical Trial
Official title:
Analyzing Engagement Trends in Rhabdomyosarcoma Clinical Trials: A Study of Participation Patterns Among Those Affected by the Disorder
| NCT number | NCT06029465 |
| Other study ID # | 84447609 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2024 |
| Est. completion date | October 2026 |
The study seeks to delve into the firsthand experiences of patients diagnosed with rhabdomyosarcoma who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. The data collected from this study will help improve future outcomes for all rhabdomyosarcoma patients as well as those in under-represented demographic groups.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | October 2026 |
| Est. primary completion date | October 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosis of rhabdomyosarcoma - Considered reliable, able to understand, and willing to perform all study procedures - Signed Written Informed Consent Exclusion Criteria: - Currently enrolled in, have completed or have discontinued from a clinical trial involving an investigational drug - Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study - Any serious and/or unstable pre-existing medical disorders |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Leiner J, Le Loarer F. The current landscape of rhabdomyosarcomas: an update. Virchows Arch. 2020 Jan;476(1):97-108. doi: 10.1007/s00428-019-02676-9. Epub 2019 Nov 6. — View Citation
Saulnier-Sholler G, Duda DG, Bergendahl G, Ebb D, Snuderl M, Laetsch TW, Michlitsch J, Hanson D, Isakoff MS, Bielamowicz K, Kraveka JM, Ferguson W, Carmeliet P, De Deene A, Gijsen L, Jain RK. A Phase I Trial of TB-403 in Relapsed Medulloblastoma, Neuroblastoma, Ewing Sarcoma, and Alveolar Rhabdomyosarcoma. Clin Cancer Res. 2022 Sep 15;28(18):3950-3957. doi: 10.1158/1078-0432.CCR-22-1169. — View Citation
Sparber-Sauer M, Ferrari A, Kosztyla D, Ladenstein R, Cecchetto G, Kazanowska B, Scarzello G, Ljungman G, Milano GM, Niggli F, Alaggio R, Vokuhl C, Casanova M, Klingebiel T, Zin A, Koscielniak E, Bisogno G. Long-term results from the multicentric European randomized phase 3 trial CWS/RMS-96 for localized high-risk soft tissue sarcoma in children, adolescents, and young adults. Pediatr Blood Cancer. 2022 Sep;69(9):e29691. doi: 10.1002/pbc.29691. Epub 2022 Apr 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of rhabdomyosarcoma patients who decide to enroll in a clinical trial | 3 months | ||
| Primary | Rate of rhabdomyosarcoma patients who remain in clinical trial to trial completion | 12 months |
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