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A Patient-Centric Platform Trial for Precision Oncology (XCELSIOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03793088
Recruitment Status : Recruiting
First Posted : January 4, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
xCures
Musella Foundation for Brain Tumor Research and Information, Inc.
Information provided by (Responsible Party):
Cancer Commons

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
Oncology

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.

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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 :
  1. Progression Free Survival (PFS) [ Time Frame: 5 Years ]
  2. Overall Survival (OS) [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   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
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Contact: Bryan J Federowicz 919-812-1288 bfederowicz@xcures.com

Locations
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United States, California
Cancer Commons Recruiting
Los Altos, California, United States, 94022
Contact: Bryan Federowicz         
Sponsors and Collaborators
Cancer Commons
xCures
Musella Foundation for Brain Tumor Research and Information, Inc.
Investigators
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Principal Investigator: Mark Shapiro xCures / Cancer Commons

Additional Information:
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Responsible Party: Cancer Commons
ClinicalTrials.gov Identifier: NCT03793088     History of Changes
Other Study ID Numbers: XC3-GCTA-2018
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Commons:
Glioblastoma
Glioma
Pancreatic Adenocarcinoma
Additional relevant MeSH terms:
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Neoplasms