CancermyCare-102NCT05693831
myCare-102: Clinical Utility and Usability of Cellworks Singula™ and Cellworks Ventura™ Reports
An observational study of Cancer and Relapsed Cancer, run by Cellworks Group Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Relapsed Cancer, Refractory Cancer
- What is being tested?
- Cellworks Report
- How many people
- 730 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57108
Tobias Meissner, MD
About this study
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
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
- Being tested
- Cellworks Report
- Keywords
- cancer, relapsed/refractory, second-line therapy, third-line therapy, received first-line therapy
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellworks ReportOther
Also called Cellworks Singula Report, Cellworks Ventura 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.
| Study group | Role | What they receive |
|---|---|---|
| Singula | Patients with a diagnosis of cancer who have already received first line therapy Receives: Other: Cellworks Report | |
| Ventura | Patients with a diagnosis of relapsed or refractory cancer Receives: Other: Cellworks Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surveyed View of Cellworks Singula and Ventura™ reports
Majority of physicians and molecular tumor boards (MTB) have a positive view of the Cellworks Singula™ and Cellworks Ventura™ reports
Measured: Approximately 24 months
Secondary outcomes (8)
Patient Demographics (Sex)
Patient Sex
Measured: Approximately 24 months
Patient Demographics (Ethnicity)
Ethnicity
Measured: Approximately 24 months
Patient Demographics (Age)
Age
Measured: Approximately 24 months
Institution Demographics (Type)
Institution Type
Measured: Approximately 24 months
Institution Demographics (Orders Placed)
Number of Orders Placed
Measured: Approximately 24 months
Institution Demographics (Placement of Orders)
Placement Within Orders
Measured: Approximately 24 months
Patient Disease Status (Indication)
Disease Indication
Measured: Approximately 24 months
Patient Disease Status (ECOG)
ECOG Score
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Dec 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellworks Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Howard, M.D., Principal investigator, University of TN Health Science CenterTobias Meissner, Dr. sc. hum., Principal investigator, Avera Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693831
- Sponsor's protocol ID
- myCare-102
- Acronym
- myCare-102
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05693831
- Acronym / sponsor ID
- myCare-102 / myCare-102
- Conditions
- Cancer, Relapsed Cancer, Refractory Cancer
- Keywords
- cancer, relapsed/refractory, second-line therapy, third-line therapy, received first-line therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Cellworks Group Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Singula | – | Other: Cellworks ReportPatients with a diagnosis of cancer who have already received first line therapy |
| Ventura | – | Other: Cellworks ReportPatients with a diagnosis of relapsed or refractory cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cellworks ReportAlso: Cellworks Singula Report, Cellworks Ventura ReportSurvey physicians and molecular tumor board perspectives of the benefit of Cellworks Singula™ and Ventura™ reports in facilitating treatment decisions in pan-cancer patients. | Other | Singula, Ventura |
Primary outcome
Surveyed View of Cellworks Singula and Ventura™ reports
Time frame: Approximately 24 months
Majority of physicians and molecular tumor boards (MTB) have a positive view of the Cellworks Singula™ and Cellworks Ventura™ reports
8 secondary outcomes
Patient Demographics (Sex)
Time frame: Approximately 24 months
Patient Demographics (Ethnicity)
Time frame: Approximately 24 months
Patient Demographics (Age)
Time frame: Approximately 24 months
Institution Demographics (Type)
Time frame: Approximately 24 months
Institution Demographics (Orders Placed)
Time frame: Approximately 24 months
Institution Demographics (Placement of Orders)
Time frame: Approximately 24 months
Patient Disease Status (Indication)
Time frame: Approximately 24 months
Patient Disease Status (ECOG)
Time frame: Approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Howard, M.D. principal investigator
University of TN Health Science Center
Tobias Meissner, Dr. sc. hum. principal investigator
Avera Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Relapsed Cancer, run by Cellworks Group Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michele Macpherson ((650)346-9980, michele.macpherson@cellworksgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surveyed View of Cellworks Singula and Ventura™ reports (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.