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

Cancer Clinical Trial

— myCare-102  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05693831
• Other study ID #: myCare-102
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2023
• Source: Cellworks Group Inc.
• Contact: Michele Macpherson
• Phone: (650)346-9980
• Email: michele.macpherson[@]cellworksgroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 730
• Est. completion date: December 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Refractory Cancer
• Relapsed Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Avera Cancer Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Cellworks Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Demographics (Sex)	Patient Sex	Approximately 24 months
Secondary	Patient Demographics (Ethnicity)	Ethnicity	Approximately 24 months
Secondary	Patient Demographics (Age)	Age	Approximately 24 months
Secondary	Institution Demographics (Type)	Institution Type	Approximately 24 months
Secondary	Institution Demographics (Orders Placed)	Number of Orders Placed	Approximately 24 months
Secondary	Institution Demographics (Placement of Orders)	Placement Within Orders	Approximately 24 months
Secondary	Patient Disease Status (Indication)	Disease Indication	Approximately 24 months
Secondary	Patient Disease Status (ECOG)	ECOG Score	Approximately 24 months