Determining Patterns In Study Experiences of Neuroblastoma Patients

Neuroblastoma Clinical Trial

Official title:

Neuroblastoma Clinical Trials: Looking at Patterns About How Patients Feel About Participating in Clinical Trials

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05918432
• Other study ID #: 81920705
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: June 2023
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: (415) 900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Historically, participation in clinical research is highly skewed towards particular demographic groups of people. This study will invite several participants to gather a wide range of information on clinical trial experiences for neuroblastoma 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 neuroblastoma. The data collected from this study will help improve future outcomes for all neuroblastoma patients as well as those in under-represented demographic groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of neuroblastoma
• 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:

• Women of childbearing potential without a negative pregnancy test; or women who are lactating.
• Any serious and/or unstable pre-existing medical disorders
• Enrolled in another research study

Related Conditions & MeSH terms

• Neuroblastoma

Locations

Country	Name	City	State
United States	Power Life Sciences	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Khomenko VI, Stoliarchuk NP, Ilyk OP. [Reserves of quality]. Veterinariia. 1979 Mar;(3):14-6. No abstract available. Russian. — View Citation

Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, Tenney SC, Haas-Kogan D, Shaw PJ, Kraveka JM, Roberts SS, Geiger JD, Doski JJ, Voss SD, Maris JM, Grupp SA, Diller L. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):746-755. doi: 10.1001/jama.2019.11642. — View Citation

Park JR, Villablanca JG, Hero B, Kushner BH, Wheatley K, Beiske KH, Ladenstein RL, Baruchel S, Macy ME, Moreno L, Seibel NL, Pearson AD, Matthay KK, Valteau-Couanet D. Early-phase clinical trial eligibility and response evaluation criteria for refractory, relapsed, or progressive neuroblastoma: A consensus statement from the National Cancer Institute Clinical Trials Planning Meeting. Cancer. 2022 Nov 1;128(21):3775-3783. doi: 10.1002/cncr.34445. Epub 2022 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who decide to enroll in a neuroblastoma clinical trial		3 months
Primary	Rate of patients who remain in neuroblastoma clinical trial to trial completion		12 months