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Trial Title:
myCare-102: Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports
NCT ID:
NCT05693831
Condition:
Cancer
Relapsed Cancer
Refractory Cancer
Conditions: Keywords:
cancer
relapsed/refractory
second-line therapy
third-line therapy
received first-line therapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Cellworks Report
Description:
Survey physicians and molecular tumor board perspectives of the benefit of Cellworks
Singula™ and Ventura™ reports in facilitating treatment decisions in pan-cancer patients.
Arm group label:
Singula
Arm group label:
Ventura
Other name:
Cellworks Singula Report
Other name:
Cellworks Ventura Report
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.
Criteria for eligibility:
Study pop:
- 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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Avera Cancer Institute
Address:
City:
Sioux Falls
Zip:
57108
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tobias Meissner, MD
Start date:
December 1, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Cellworks Group Inc.
Agency class:
Industry
Source:
Cellworks Group Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05693831
