Recruiting

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

Sponsor:

Cellworks Group Inc.

Code:

NCT05693831

Conditions

Cancer

Relapsed Cancer

Refractory Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cellworks Report

Study Details

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.

Conditions

Cancer

Relapsed Cancer

Refractory Cancer

Study ID

NCT05693831

Start date

Dec 1, 2022

Status verified date

Jan, 2023

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Apr 1, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

730 participants

Anticipated

Interventions and Outcome Measures

Arms

Singula

Patients with a diagnosis of cancer who have already received first line therapy

Ventura

Patients with a diagnosis of relapsed or refractory cancer

Interventions

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.

Primary outcome measure

Surveyed View of Cellworks Singula and Ventura™ reports [ Time Frame: Approximately 24 months ]

Central Contacts and Locations

Central contacts

Michele Macpherson

(650)346-9980 michele.macpherson@cellworksgroup.com

Locations

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57108

More Information

Sponsor

Cellworks Group Inc.

Last update posted

Jan 23, 2023

Last verified

Jan, 2023

Keywords

cancer
relapsed/refractory
second-line therapy
third-line therapy
received first-line therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cellworks Group Inc. on 2023-01-23.