myCare-102: Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports (myCare-102)

myCare-102: A Survey of Physician and Molecular Tumor Board Perspectives on the Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports in Facilitating Patient Treatment Decisions for Pan-Cancer Patients

The purpose of this study is to determine the benefit of Cellworks Singula™ reports on physician and molecular tumor board treatment recommendations across a large set of pan-cancer indications who have already received first-line therapy. The study is also to determine the benefit of Cellworks Ventura™ reports on physician and molecular tumor board treatment recommendations across a large set of relapsed or refractory pan-cancer indications.

The primary objective of this study is to survey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™and Cellworks Ventura™ reports in facilitating treatment decisions in pan-cancer patients.

Cellworks reports aim to provide NGS-based therapy recommendations to aid the decision-making of patients, physicians, and molecular tumor boards. 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: Cancer; Relapsed Cancer; Refractory Cancer
• Intervention / Treatment: Other: Cellworks Report

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

Contacts and Locations

• Study Contact: Name: Michele Macpherson; Phone Number: (650)346-9980; Email: michele.macpherson@cellworksgroup.com

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Recruiting
      • Avera Cancer Institute
      • Contact: Tobias Meissner, MD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

• Patients with a diagnosis of cancer who have already received first line therapy, for Cellworks Singula™ report.
• Patients with a diagnosis of relapsed or refractory cancer, for Cellworks Ventura™ report.

Description

Inclusion Criteria:

• Have cancer for the indications listed at: https://cellworks.life/mycare102. Patients are eligible at any stage of the disease.
• Have already received first-line therapy
• For Cellworks Singula™ report, patients must be Relapsed or refractory after first-line treatment.
• For Cellworks Ventura™ report, patients must have relapsed or refractory cancer and have exhausted standard of care therapy options
• 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/mycare102
• 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 then Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered. If Acute Myeloid Leukemia (AML) then FLT3-itd testing has been ordered. If the Indication is a form of Brain Cancer (e.g., glioblastoma) then Cytogenetics in the form of FISH, Karyotyping, IHC, and/or aCGH has been ordered and MGMT Methylation test has been ordered.

Exclusion Criteria:

• Patients not previously diagnosed with cancer of any of the indications listed at: https://cellworks.life/mycare102
• Patients without an NGS report ordered/performed within the past 90 days
• Patients who are expected to be alive less than 6 months
• Pregnant women
• Patients who have not exhausted standard-of-care treatment options or who have known effective therapy
• Patients that fall into the following categories based on survey response will considered excluded from eligibility: If recommendations were made before receiving the Cellworks report, patients will not be included in the primary analysis but will be included in the ITT analysis. If recommended an FDA approved therapy that was not included on the Cellworks report. If recommended a clinical trial for a therapy that was not included in the Cellworks report. If the therapy/therapies on the Cellworks report was/were not covered by the patient's insurance. If the therapy/therapies on the Cellworks report was/were too expensive.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Singula; Patients with a diagnosis of cancer who have already received first line therapy	Other: Cellworks Report; Survey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™ and Ventura™ reports in facilitating treatment decisions in pan-cancer patients.; Other Names: Cellworks Singula Report; Cellworks Ventura Report
Ventura; Patients with a diagnosis of relapsed or refractory cancer	Other: Cellworks Report; Survey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™ and Ventura™ reports in facilitating treatment decisions in pan-cancer patients.; Other Names: Cellworks Singula Report; Cellworks Ventura Report

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surveyed View of Cellworks Singula and Ventura™ reports	Majority of physicians and molecular tumor boards (MTB) have a positive view of the Cellworks Singula™ and Cellworks Ventura™ reports	Approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Demographics (Sex)	Patient Sex	Approximately 24 months
Patient Demographics (Ethnicity)	Ethnicity	Approximately 24 months
Patient Demographics (Age)	Age	Approximately 24 months
Institution Demographics (Type)	Institution Type	Approximately 24 months
Institution Demographics (Orders Placed)	Number of Orders Placed	Approximately 24 months
Institution Demographics (Placement of Orders)	Placement Within Orders	Approximately 24 months
Patient Disease Status (Indication)	Disease Indication	Approximately 24 months
Patient Disease Status (ECOG)	ECOG Score	Approximately 24 months

Collaborators and Investigators

• Sponsor: Cellworks Group Inc.
• Investigators: Principal Investigator: Scott Howard, M.D., University of TN Health Science Center; Principal Investigator: Tobias Meissner, Dr. sc. hum., Avera Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 20, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cancer; second-line therapy; relapsed/refractory; third-line therapy; received first-line therapy
• Other Study ID Numbers: myCare-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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