Determining Patterns In Study Experiences of Neuroblastoma Patients

NCT ID: NCT05918432

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuroblastoma

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

References

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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.

Reference Type BACKGROUND
PMID: 31454045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36101004 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 442501 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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81920705

Identifier Type: -

Identifier Source: org_study_id

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