Clinical trial NCT05929547: Patient Perspectives in Squamous Cell Carcinoma Clinical Trials
Official title: An In Depth Study Examining Patterns in the Clinical Trial Experiences of Squamous Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Squamous Cell Carcinoma
Keywords: squamous cell carcinoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-03
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: Patients with squamous cell carcinoma who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Clinical research participation has historically been heavily biased toward specific demographics.

This study will invite several participants to gather a wide range of information on clinical trial experiences for squamous cell carcinoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of squamous cell carcinoma.

People with squamous cell carcinoma who are invited to take part in clinical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Confirmed diagnosis of squamous cell carcinoma
* 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:

* Inability to provide written informed consent
* Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
* Enrolled in another research study

Primary outcomes:
measure: Number of patients who decide to enroll in a squamous cell carcinoma clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in squamous cell carcinoma clinical trial to trial completion
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: Leis M, Singh A, Li C, Ahluwalia R, Fleming P, Lynde CW. Risk of Vulvar Squamous Cell Carcinoma in Lichen Sclerosus and Lichen Planus: A Systematic Review. J Obstet Gynaecol Can. 2022 Feb;44(2):182-192. doi: 10.1016/j.jogc.2021.09.023. Epub 2021 Oct 19.
citation: Gupta S, Kamboj M, Narwal A. Knowing the unknown in oral squamous cell carcinoma: An observational study. J Cancer Res Ther. 2020 Apr-Jun;16(3):494-499. doi: 10.4103/jcrt.JCRT_898_18.
citation: Schlessinger DI, Iyengar S, Yanes AF, Chiren SG, Godinez-Puig V, Chen BR, Kurta AO, Schmitt J, Deckert S, Furlan KC, Poon E, Cartee TV, Maher IA, Alam M, Sobanko JF. Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2017 Jul 12;18(1):321. doi: 10.1186/s13063-017-2069-2.