Clinical trial NCT05693831: myCare-102: Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Relapsed Cancer
Refractory Cancer
Keywords: cancer
relapsed/refractory
second-line therapy
third-line therapy
received first-line therapy
Lead sponsor: Cellworks Group Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 730
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Surveyed View of Cellworks Singula and Ventura™ reports
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Patient Demographics (Sex)
timeFrame: Approximately 24 months
measure: Patient Demographics (Ethnicity)
timeFrame: Approximately 24 months
measure: Patient Demographics (Age)
timeFrame: Approximately 24 months
measure: Institution Demographics (Type)
timeFrame: Approximately 24 months
measure: Institution Demographics (Orders Placed)
timeFrame: Approximately 24 months
measure: Institution Demographics (Placement of Orders)
timeFrame: Approximately 24 months
measure: Patient Disease Status (Indication)
timeFrame: Approximately 24 months
measure: Patient Disease Status (ECOG)
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
Study officials:
affiliation: University of TN Health Science Center
name: Scott Howard, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Avera Cancer Institute
name: Tobias Meissner, Dr. sc. hum.
role: PRINCIPAL_INVESTIGATOR
References: