RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-12-01
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05693831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have cancer for the indications listed at: https://cellworks.life/mycare102. Patients are eligible at any stage of the disease.
  2. * Have already received first-line therapy
  3. * For Cellworks Singula™ report, patients must be Relapsed or refractory after first-line treatment.
  4. * For Cellworks Ventura™ report, patients must have relapsed or refractory cancer and have exhausted standard of care therapy options
  5. * Expected to be alive 6 months or more
  6. * Requirements for NGS testing (e.g., panel or whole-exome sequencing)
  7. * NGS testing has been ordered from or performed by one or more vendors specified at: https://cellworks.life/mycare102
  8. * NGS reports must be ordered or performed within the last 90 days
  9. * Cellworks will accept all NGS input formats available, including PDF, VCF, BAM, and FastQ.
  10. * 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.
  1. * Patients not previously diagnosed with cancer of any of the indications listed at: https://cellworks.life/mycare102
  2. * Patients without an NGS report ordered/performed within the past 90 days
  3. * Patients who are expected to be alive less than 6 months
  4. * Pregnant women
  5. * Patients who have not exhausted standard-of-care treatment options or who have known effective therapy
  6. * 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

Study Contact

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

Principal Investigator

Scott Howard, M.D.
PRINCIPAL_INVESTIGATOR
University of TN Health Science Center
Tobias Meissner, Dr. sc. hum.
PRINCIPAL_INVESTIGATOR
Avera Cancer Institute

Study Locations (Sites)

Avera Cancer Institute
Sioux Falls, South Dakota, 57108
United States

Collaborators and Investigators

Sponsor: Cellworks Group Inc.

  • Scott Howard, M.D., PRINCIPAL_INVESTIGATOR, University of TN Health Science Center
  • Tobias Meissner, Dr. sc. hum., PRINCIPAL_INVESTIGATOR, Avera Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2022-12-01
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Cancer
  • Relapsed Cancer
  • Refractory Cancer