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

Sponsor

Avera McKennan Hospital & University Health Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05308784

Collaborator

Cellworks Group Inc. (Industry)

730

Enrollment

Location

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pan-cancer	Other: Cellworks Singula and Ventura reports

Study Design

Study Type:

Observational

Anticipated Enrollment :

730 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

Physician satisfaction on Cellworks reports [2022.1 - 2023.1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Have any stage of cancer for the indications listed at: https://cellworks.life/mycare101 Patients are eligible at any stage of disease.
Expected to be alive 6 months or more
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.
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Avera McKennan	Sioux Falls	South Dakota	United States	57105

Sponsors and Collaborators

Avera McKennan Hospital & University Health Center
Cellworks Group Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tobias Meissner, Manager -- Cancer Genomics, Avera McKennan Hospital & University Health Center

ClinicalTrials.gov Identifier:

NCT05308784

Other Study ID Numbers:

myCare-101

First Posted:

Apr 4, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 4, 2022