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

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.

Study Overview

• Status: Recruiting
• Conditions: Pan-cancer
• Intervention / Treatment: Other: Cellworks Singula and Ventura reports

• Study Type: Observational
• Enrollment (Estimated): 730

Contacts and Locations

• Study Contact: Name: Tobias Meissner, PhD; Phone Number: 605-322-3894; Email: tobias.meissner@avera.org

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera McKennan
      • Contact: Tobias Meissner, PhD; Phone Number: 605-322-3894; Email: tobias.meissner@avera.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with a diagnosis of cancer at any stage

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Collaborators: Cellworks Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: myCare-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No