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

NCT05693831 | Unknown DMC

• 1 other identifier: myCare-102
• 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™ 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.

Conditions

Cancer; Relapsed Cancer; Refractory Cancer

Keywords

cancer; relapsed/refractory; second-line therapy; third-line therapy; received first-line therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient Demographics (Sex)

  Approximately 24 months

• Patient Demographics (Ethnicity)

  Approximately 24 months

• Patient Demographics (Age)

  Approximately 24 months

• Institution Demographics (Type)

  Approximately 24 months

• Institution Demographics (Orders Placed)

  Approximately 24 months

Study Arms (2)

Singula

Patients with a diagnosis of cancer who have already received first line therapy

Other: Cellworks Report

Ventura

Patients with a diagnosis of relapsed or refractory cancer

Other: Cellworks Report

Interventions

Cellworks Report OTHER

Survey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™ and Ventura™ reports in facilitating treatment decisions in pan-cancer patients.

Also known as: Cellworks Singula Report, Cellworks Ventura Report

Singula; Ventura

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cellworks Group Inc.: lead

Study Sites (1)

Avera Cancer Institute

Sioux Falls, South Dakota, 57108, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Howard, M.D.

  University of TN Health Science Center

  PRINCIPAL INVESTIGATOR

• Tobias Meissner, Dr. sc. hum.

  Avera Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Macpherson

CONTACT

(650)346-9980; michele.macpherson@cellworksgroup.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: December 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: December 1, 2025
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)