NCT06029465

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

September 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 1, 2023

Last Update Submit

September 1, 2023

Conditions

Keywords

Rhabdomyosarcoma

Outcome Measures

Primary Outcomes (2)

  • Number of rhabdomyosarcoma patients who decide to enroll in a clinical trial

    3 months

  • Rate of rhabdomyosarcoma patients who remain in clinical trial to trial completion

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rhabdomyosarcoma who are actively considering enrolling in an observational clinical study for said condition, but have not yet completed enrollment and randomization phases.

You may qualify if:

  • Diagnosis of rhabdomyosarcoma
  • Considered reliable, able to understand, and willing to perform all study procedures
  • Signed Written Informed Consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

  • 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.

    PMID: 35441463BACKGROUND
  • 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.

    PMID: 35833850BACKGROUND
  • 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.

    PMID: 31696361BACKGROUND

MeSH Terms

Conditions

Rhabdomyosarcoma

Condition Hierarchy (Ancestors)

MyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcoma

Study Officials

  • Michael B Gill

    Power Life Sciences Inc.

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2023

First Posted

September 8, 2023

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations