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XCELSIOR: A Patient-Centric Platform Trial for Precision Oncology

Sponsor
xCures (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03793088
Collaborator
Cancer Commons (Other), Musella Foundation for Brain Tumor Research and Information, Inc. (Other), Pediatric Oncology Experimental Therapeutics Investigators Consortium (Other)
10,000
Enrollment
1
Location
82.8
Anticipated Duration (Months)
120.8
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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 :
    Feb 7, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [5 Years]

    2. Overall Survival (OS) [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Commons Los Altos California United States 94022

    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)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    xCures
    ClinicalTrials.gov Identifier:
    NCT03793088
    Other Study ID Numbers:
    • XC3-GCTA-2018
    First Posted:
    Jan 4, 2019
    Last Update Posted:
    Apr 12, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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
    Glioblastoma
    Glioma
    Pancreatic Adenocarcinoma
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2021