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xDRIVE in Metastatic Colorectal Cancer

NCT06929338 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-09-16

No results posted yet for this study

Summary

The study aims to evaluate the clinical utility of the xDRIVE functional precision medicine + artificial intelligence (AI) platform in predicting treatment response for metastatic colorectal cancer (mCRC). The primary objective is to assess xDRIVE's accuracy in forecasting clinical benefit from standard-of-care (SOC) therapies, with a target of ≥80% accuracy in 25 participants. Achieving this threshold would provide sufficient statistical power to reject the null hypothesis of ≤50% accuracy.

The secondary goal is to determine the feasibility of utilizing xDRIVE for timely treatment recommendations. Success will be defined by the ability to provide recommendations within four weeks for at least 64% of patients, ensuring clinical applicability.

Additionally, the study includes an exploratory objective to examine oncologists' perspectives on integrating xDRIVE into clinical decision-making. This will be achieved through a post-hoc survey assessing physician experiences with the precision oncology platform.

Conditions

  • Metastatic Colon Adenocarcinoma
  • Metastatic Colon Cancer
  • Metastatic Rectal Adenocarcinoma
  • Metastatic Rectal Carcinoma
  • Metastatic Rectum Cancer

Interventions

DIAGNOSTIC_TEST

Functional precision medicine

The results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices. Treatment will not be given as part of the study.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Florida International University

    collaborator OTHER

  • First Ascent Biomedical Inc.

    lead INDUSTRY

Principal Investigators

  • Noah Berlow, PhD · First Ascent Biomedical

  • Hao Xie, MD PhD · Mayo Clinic

  • Lisa Boardman, MD · Mayo Clinic

  • Diana J Azzam, PhD · Florida International University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2026-06-30
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06929338 on ClinicalTrials.gov