myCare-102: Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Surveyed View of Cellworks Singula and Ventura™ reports [Approximately 24 months]
Majority of physicians and molecular tumor boards (MTB) have a positive view of the Cellworks Singula™ and Cellworks Ventura™ reports
Secondary Outcome Measures
- Patient Demographics (Sex) [Approximately 24 months]
Patient Sex
- Patient Demographics (Ethnicity) [Approximately 24 months]
Ethnicity
- Patient Demographics (Age) [Approximately 24 months]
Age
- Institution Demographics (Type) [Approximately 24 months]
Institution Type
- Institution Demographics (Orders Placed) [Approximately 24 months]
Number of Orders Placed
- Institution Demographics (Placement of Orders) [Approximately 24 months]
Placement Within Orders
- Patient Disease Status (Indication) [Approximately 24 months]
Disease Indication
- Patient Disease Status (ECOG) [Approximately 24 months]
ECOG Score
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57108 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- myCare-102