Clinical trial NCT06264505: Investigative Analysis of Soft Tissue Sarcoma Clinical Trials: An Observational Study
Official title: Probing Participation in Soft Tissue Sarcoma Research: An Observational Study of Soft Tissue Sarcoma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Soft Tissue Sarcoma
Keywords: soft tissue sarcoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of patients in soft tissue sarcoma clinical research
timeFrame: 3 months
measure: Number of soft tissue sarcoma study participants who maintain involvement until study finish
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.