A Patient-Centric Platform Trial for Precision Oncology

Recruiting

• Conditions: Oncology

• Registration Number: NCT03793088
• Lead Sponsor: xCures

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.

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 Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-03
• Study First Posted: 2019-01-04
• Study Start: 2019-02-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-03
• Primary Completion: 2024-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	5 years
Progression Free Survival (PFS)	5 Years

Trial Locations

Locations (1)

Cancer Commons; 🇺🇸 Los Altos, California, United States