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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date September 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone (415) 900-4227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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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