A Patient-Centric Platform Trial for Precision Oncology (XCELSIOR)
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| ClinicalTrials.gov Identifier: NCT03793088 |
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Recruitment Status :
Recruiting
First Posted : January 4, 2019
Last Update Posted : February 3, 2023
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Sponsor:
xCures
Collaborators:
Cancer Commons
Musella Foundation for Brain Tumor Research and Information, Inc.
Pediatric Oncology Experimental Therapeutics Investigators Consortium
Information provided by (Responsible Party):
xCures
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Brief 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.
| Condition or disease |
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| Oncology |
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 Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | xCures/CancerCommons Enhanced Learning Treatment Selection and Analysis With Outcomes Research (XCELSIOR) Study: A Patient-Centric Platform Trial for Precision Oncology |
| Actual Study Start Date : | February 7, 2019 |
| Estimated Primary Completion Date : | January 2024 |
| Estimated Study Completion Date : | January 2026 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: 5 Years ]
- Overall Survival (OS) [ Time Frame: 5 years ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 0 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
This study will initially include up to 10,000 adult and pediatric patients with recalcitrant or advanced cancers.
Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Patients must be a resident of or receiving care within the United States or US territories.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793088
Contacts
| Contact: Bryan J Federowicz | 707-641-4475 | bfederowicz@xcures.com |
Locations
| United States, California | |
| Cancer Commons | Recruiting |
| Los Altos, California, United States, 94022 | |
| Contact: Bryan Federowicz | |
Sponsors and Collaborators
xCures
Cancer Commons
Musella Foundation for Brain Tumor Research and Information, Inc.
Pediatric Oncology Experimental Therapeutics Investigators Consortium
Investigators
| Principal Investigator: | Mark Shapiro | xCures / Cancer Commons |
Study Documents (Full-Text)
Additional Information:
| Responsible Party: | xCures |
| ClinicalTrials.gov Identifier: | NCT03793088 |
| Other Study ID Numbers: |
XC3-GCTA-2018 |
| First Posted: | January 4, 2019 Key Record Dates |
| Last Update Posted: | February 3, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by xCures:
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Glioblastoma Glioma Pancreatic Adenocarcinoma |
Additional relevant MeSH terms:
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Neoplasms |