Exploring Clinical Trial Experiences of People With Leiomyosarcoma

NCT05548179 | Unknown

• 1 other identifier: 87688730
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Leiomyosarcoma

Keywords

leiomyosarcoma

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in an leiomyosarcoma clinical trial

  3 months

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

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Leiomyosarcoma patients who are actively considering participating in an interventional clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

• Patient does not understand, sign, and return consent form
• Inability to perform regular electronic reporting
• Patient is pregnant
• ECOG score of 4

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 34298376 BACKGROUND

• 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.

  PMID: 24093170 BACKGROUND

• 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.

  PMID: 35275323 BACKGROUND

MeSH Terms

Conditions

Leiomyosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

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

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2022-09