A Close Examination of Patient Experiences in Glioblastoma Multiforme Clinical Research

NCT05958485 | Not Yet Recruiting

• 1 other identifier: 82196870
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical research can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in glioblastoma multiforme clinical study, as well as the reasons for withdrawal or discontinuation. Insights gained from this study will ultimately benefit those with glioblastoma multiforme who may be invited to participate in clinical trial in the years to come.

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma multiforme

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to enroll in a glioblastoma multiforme clinical study.

  3 months

• Number of glioblastoma multiforme study participants who remain in clinical trial until 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

Patients with glioblastoma multiforme who are actively considering participating in an observational clinical study, but have not yet completed enrollment and randomization.

You may qualify if:

• Diagnosis of glioblastoma multiforme
• No prior treatment for glioblastoma multiforme
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Female patients who are currently pregnant or nursing
• Enrolled in another research study
• Patients who are currently receiving any other investigational drug.

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Michaelsen SR, Christensen IJ, Grunnet K, Stockhausen MT, Broholm H, Kosteljanetz M, Poulsen HS. Clinical variables serve as prognostic factors in a model for survival from glioblastoma multiforme: an observational study of a cohort of consecutive non-selected patients from a single institution. BMC Cancer. 2013 Sep 3;13:402. doi: 10.1186/1471-2407-13-402.

  PMID: 24004722 BACKGROUND

• Tosoni A, Gatto L, Franceschi E, Di Nunno V, Lodi R, Mura A, Di Battista M, Bartolini S, Brandes AA. Association between socioeconomic status and survival in glioblastoma: An Italian single-centre prospective observational study. Eur J Cancer. 2021 Mar;145:171-178. doi: 10.1016/j.ejca.2020.12.027. Epub 2021 Jan 22.

  PMID: 33486440 BACKGROUND

• Ruda R, Bruno F, Pellerino A, Pronello E, Palmiero R, Bertero L, Crasto S, Polo V, Vitaliani R, Trincia E, Interno V, Porta C, Soffietti R. Observational real-life study on regorafenib in recurrent glioblastoma: does dose reduction reduce toxicity while maintaining the efficacy? J Neurooncol. 2022 Nov;160(2):389-402. doi: 10.1007/s11060-022-04155-9. Epub 2022 Oct 30.

  PMID: 36309895 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

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: July 14, 2023
• First Posted: July 24, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 24, 2023

Record last verified: 2023-07

Locations

US (1)