OncologyXCELSIORNCT03793088
A Patient-Centric Platform Trial for Precision Oncology
An observational study of Oncology, run by xCures at 1 site in United States.
Trial summary
XCELSIOR is a non-interventional data registry. Information about treatments, treatment decisions and rationale, and patient outcomes including safety and effectiveness of anti-cancer therapy and associated supportive care will be collected for analysis. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Oncology
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2019to Jan 2026
- How long will I take part?
- 5 Years
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will initially include up to 10,000 adult and pediatric patients with recalcitrant or advanced cancers.
Who may be able to join
- Both male and female patients with known or suspected recalcitrant or advanced cancer are eligible to enroll through the Cancer Commons Website
- Patients with any performance status, comorbidity or disease severity are eligible
- Patients or their legally-authorized representative must be willing and able to provide written, informed consent (and assent, if applicable)
Who cannot join
- Patients must be a resident of or receiving care within the United States or US territories.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cancer Commons
Los Altos, California, 94022
Bryan Federowicz
About this study
Official title: xCures/CancerCommons Enhanced Learning Treatment Selection and Analysis With Outcomes Research (XCELSIOR) Study: A Patient-Centric Platform Trial for Precision Oncology
XCELSIOR is a non-interventional data registry. Information about treatments, treatment decisions and rationale, and patient outcomes including safety and effectiveness of anti-cancer therapy and associated supportive care will be collected for analysis.
Read the detailed description
XCELSIOR is patient-centric study for the registration of cancer patients, operations of a virtual tumor board, insight capture in clinical decision making, and collection of longitudinal, observational data in a cancer registry. Patient intake into XCELSIOR will occur through the Cancer Commons Web portal. This includes consent to participate in the data registry, including the collection and review of medical information by a Virtual Tumor Board, generation of patient-specific treatment options with supporting rationale, access to treatment access support services, and inclusion into a registry study that includes safety and efficacy outcomes tracking. Patients will be treated and tracked in their original treatment setting and the data generated will form part of a systematic framework combining expert judgment with artificial intelligence to maximize information gain and improve treatment option set development for individual cancer patients.
- Conditions
- Oncology
- Keywords
- Glioblastoma, Glioma, Pancreatic Adenocarcinoma
- Medical subject headings
- Neoplasms, Glioblastoma, Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: 5 Years
Overall Survival (OS)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start7 Feb 2019
- Primary completionJan 2024 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- 10,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- xCures
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Commons, Musella Foundation for Brain Tumor Research and Information, Inc., The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
- Responsible party
- Sponsor
- Investigators
- Mark Shapiro, Principal investigator, xCures / Cancer Commons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793088
- Sponsor's protocol ID
- XC3-GCTA-2018
- Acronym
- XCELSIOR
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2019
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- xCures/CancerCommons Enhanced Learning Treatment Selection and Analysis With Outcomes Research (XCELSIOR) Study: A Patient-Centric Platform Trial for Precision Oncology
- ClinicalTrials.gov ID
- NCT03793088
- Acronym / sponsor ID
- XCELSIOR / XC3-GCTA-2018
- Conditions
- Oncology
- Keywords
- Glioblastoma, Glioma, Pancreatic Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- xCuresIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Commons, Musella Foundation for Brain Tumor Research and Information, Inc., The Pediatric Oncology Experimental Therapeutics Investigators' Consortium
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Jan 2019 (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.
XCELSIOR is a non-interventional data registry. Information about treatments, treatment decisions and rationale, and patient outcomes including safety and effectiveness of anti-cancer therapy and associated supportive care will be collected for analysis.
Detailed description
XCELSIOR is patient-centric study for the registration of cancer patients, operations of a virtual tumor board, insight capture in clinical decision making, and collection of longitudinal, observational data in a cancer registry. Patient intake into XCELSIOR will occur through the Cancer Commons Web portal. This includes consent to participate in the data registry, including the collection and review of medical information by a Virtual Tumor Board, generation of patient-specific treatment options with supporting rationale, access to treatment access support services, and inclusion into a registry study that includes safety and efficacy outcomes tracking. Patients will be treated and tracked in their original treatment setting and the data generated will form part of a systematic framework combining expert judgment with artificial intelligence to maximize information gain and improve treatment option set development for individual cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will initially include up to 10,000 adult and pediatric patients with recalcitrant or advanced cancers.
Key inclusion criteria (3 listed)
- Both male and female patients with known or suspected recalcitrant or advanced cancer are eligible to enroll through the Cancer Commons Website
- Patients with any performance status, comorbidity or disease severity are eligible
- Patients or their legally-authorized representative must be willing and able to provide written, informed consent (and assent, if applicable)
Key exclusion criteria (1 listed)
- Patients must be a resident of or receiving care within the United States or US territories.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival (PFS)
Time frame: 5 Years
Overall Survival (OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Cancer Commons WebsiteLink provided by the sponsor.
- xCures WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mark Shapiro principal investigator
xCures / Cancer Commons
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 Oncology, run by xCures 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 3 inclusion and 1 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 3 Feb 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 Bryan J Federowicz (707-641-4475, bfederowicz@xcures.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: 5 Years). The study lists 2 primary outcomes in all. 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 3 Feb 2023.