Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study

NCT06264505 | Not Yet Recruiting

• 1 other identifier: 55955210
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Generally, specific demographic cohorts exhibit higher participation rates in medical research, yet there exists a scarcity of research elucidating the trial attributes impacting the engagement of these particular demographics. The primary objective of this study is to gather extensive data on the clinical trial experiences of individuals diagnosed with soft tissue sarcoma, with the aim of identifying factors hindering patient enrollment or trial completion.

Conditions

Soft Tissue Sarcoma

Keywords

soft tissue sarcoma

Outcome Measures

Primary Outcomes (2)

• Rate of patients in soft tissue sarcoma clinical research

  3 months

• Number of soft tissue sarcoma study participants who maintain involvement until study finish

  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

Soft tissue sarcoma patients who are actively deliberating on joining a clinical trial for their condition but have yet to complete the enrollment and randomization stages.

You may qualify if:

• Patients diagnosed with soft tissue sarcoma
• Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

You may not qualify if:

• Refusal of consent
• Women of childbearing potential without a negative pregnancy test; or women who are lactating.
• Any serious and/or unstable pre-existing medical disorders

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• O'Sullivan B, Davis AM, Turcotte R, Bell R, Catton C, Chabot P, Wunder J, Kandel R, Goddard K, Sadura A, Pater J, Zee B. Preoperative versus postoperative radiotherapy in soft-tissue sarcoma of the limbs: a randomised trial. Lancet. 2002 Jun 29;359(9325):2235-41. doi: 10.1016/S0140-6736(02)09292-9.

  PMID: 12103287 BACKGROUND

• Pervaiz N, Colterjohn N, Farrokhyar F, Tozer R, Figueredo A, Ghert M. A systematic meta-analysis of randomized controlled trials of adjuvant chemotherapy for localized resectable soft-tissue sarcoma. Cancer. 2008 Aug 1;113(3):573-81. doi: 10.1002/cncr.23592.

  PMID: 18521899 BACKGROUND

• Brugemann D, Lehner B, Kieser M, Krisam J, Hommertgen A, Jaekel C, Harrabi SB, Herfarth K, Mechtesheimer G, Sedlaczek O, Egerer G, Geisbusch A, Uhl M, Debus J, Seidensaal K. Neoadjuvant irradiation of extremity soft tissue sarcoma with ions (Extrem-ion): study protocol for a randomized phase II pilot trial. BMC Cancer. 2022 May 12;22(1):538. doi: 10.1186/s12885-022-09560-x.

  PMID: 35550036 BACKGROUND

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; 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: February 9, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)