Clinical trial NCT05928377: Unveiling Patient Experiences in Testicular Cancer Clinical Trials
Official title: Patient Perspectives in Testicular Cancer Clinical Trials: Insights Into Participating in Studies for Testicular Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Testicular Cancer
Keywords: testicular cancer
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 500
Sex: MALE
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: Testicular cancer patients who are actively considering enrolling in a clinical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Clinical research 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 testicular cancer clinical study experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with testicular cancer who are invited to take part in medical research will benefit from the analysis of the data.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
* Diagnosis of testicular cancer
* No prior treatment for testicular cancer

Exclusion Criteria:

* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
* Enrolled in another research study
* Inability to provide written informed consent

Primary outcomes:
measure: Number of testicular cancer patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of testicular cancer patients who remain in a 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: Ljungman L, Eriksson LE, Flynn KE, Gorman JR, Stahl O, Weinfurt K, Wiklander M, Lampic C, Wettergren L. Sexual Dysfunction and Reproductive Concerns in Young Men Diagnosed With Testicular Cancer: An Observational Study. J Sex Med. 2019 Jul;16(7):1049-1059. doi: 10.1016/j.jsxm.2019.05.005.
citation: Selvi I, Sarikaya S, Basar H. Is testicular microlithiasis a really innocent condition? Its effects on oncological outcomes of germ cell testicular cancer: An observational study. Arch Esp Urol. 2020 Apr;73(3):215-229. English, Spanish.
citation: Pedersen MR, Sloth Osther PJ, Nissen HD, Vedsted P, Moller H, Rafaelsen SR. Elastography and diffusion-weighted MRI in patients with testicular microlithiasis, normal testicular tissue, and testicular cancer: an observational study. Acta Radiol. 2019 Apr;60(4):535-541. doi: 10.1177/0284185118786063. Epub 2018 Jul 3.