Evaluating the usefulness of Cellworks reports for cancer treatment decisions
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
This study is testing whether reports that give treatment suggestions based on genetic information can help doctors make better decisions for cancer patients whose first treatments didn't work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 730 (estimated) |
| Sex | All |
| Sponsor | Cellworks Group Inc. Industry-sponsored |
| Locations | 1 site (Sioux Falls, South Dakota) |
| Trial ID | NCT05693831 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the impact of Cellworks Singula™ and Cellworks Ventura™ reports on treatment recommendations made by physicians and molecular tumor boards for patients with cancer who have already undergone first-line therapy. The study focuses on relapsed or refractory cancer cases and seeks to understand how these reports, which provide next-generation sequencing (NGS)-based therapy recommendations, influence decision-making. By surveying healthcare professionals, the study will gather insights into the perceived benefits of these reports across various pan-cancer indications.
Who should consider this trial
Good fit: Ideal candidates include cancer patients who have received first-line therapy and are either relapsed or refractory, or have exhausted standard care options.
Not a fit: Patients who have not received first-line therapy or those with early-stage cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for cancer patients who have limited options after first-line therapy.
How similar studies have performed: While the specific approach of using Cellworks reports is novel, similar studies utilizing NGS-based recommendations have shown promise in improving treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sioux Falls, South Dakota
- Avera Cancer Institute — Sioux Falls, South Dakota, United States (Recruiting)
Study contacts
- Principal investigator: Scott Howard, M.D. — University of TN Health Science Center
- Study coordinator: Michele Macpherson
- Email: michele.macpherson@cellworksgroup.com
- Phone: (650)346-9980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.