A Survey of Physician and Molecular Tumor Board Perspectives on the Clinical Utility and Usability of Cellworks Singula™ and Ventura™ Reports in Facilitating Patient Treatment Decisions for Pan-Cancer Patients

NCT05308784 | Unknown

• 1 other identifier: myCare-101
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the benefit of Cellworks Singula™ and Ventura™ reports on physician and molecular tumor board treatment recommendations across a large set of pan-cancer indications. Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards.

Conditions

Pan-cancer

Outcome Measures

Primary Outcomes (1)

• Physician satisfaction on Cellworks reports

  A questionnaire will be administered following receipt of the Cellworks report. Survey questions will be performed using a 6-point forced response Likert scale. Simple descriptive statistics, including medians, mode and range of the resulting Likert scores, will be reported but can lead to incorrect effect size estimates, inflated error rates, and other issues (Bürkner \& Vuorre, 2019). For hypothesis testing purposes, the proportion of physicians and MTB's with a favorable response (i.e., Likert score of 4 or above) will be estimated along with exact (Clopper-Pearson) 95% two-sided confidence intervals.

  2022.1 - 2023.1

Interventions

Cellworks Singula and Ventura reports OTHER

Personalized drug match reports based on patients' genomic aberration.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of cancer at any stage

1. Have any stage of cancer for the indications listed at: https://cellworks.life/mycare101 Patients are eligible at any stage of disease. 2. Expected to be alive 6 months or more 3. Requirements for NGS testing (e.g., panel or whole-exome sequencing): NGS testing has been ordered from or performed by one or more vendors specified at: https://cellworks.life/mycare101 . NGS reports must be ordered or performed within the last 90 days. Cellworks will accept all NGS input formats available, including PDF, VCF, BAM, and FastQ. 4. Requirements for additional laboratory testing If Hematological Indication, Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered If Acute Myeloid Leukemia (AML), FLT3-itd testing has been ordered If Indication is a form of Brain Cancer (e.g., glioblastoma), Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered and MGMT Methylation test has been ordered

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Avera McKennan Hospital & University Health Center: lead
• Cellworks Group Inc.: collaborator

Study Sites (1)

Avera McKennan

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Central Study Contacts

Tobias Meissner, PhD

CONTACT

605-322-3894; tobias.meissner@avera.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager -- Cancer Genomics

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: April 4, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

US (1)