Status:
NOT_YET_RECRUITING
xDRIVE in Metastatic Colorectal Cancer
Lead Sponsor:
First Ascent Biomedical Inc.
Collaborating Sponsors:
Mayo Clinic
Florida International University
Conditions:
Metastatic Colon Adenocarcinoma
Metastatic Colon Cancer
Eligibility:
All Genders
18+ years
Brief 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 (m...
Detailed Description
Metastatic colorectal cancer (mCRC) remains a critical unmet clinical need, necessitating innovative approaches to improve patient outcomes. Functional precision medicine (FPM)-guided interventions of...
Eligibility Criteria
Inclusion
- Participants (men and women) enrolled in internal review board (IRB) 622-00 and meet the following criteria.
- Participants ≥18 years of age with a diagnosis of mCRC who are willing to consent to the study
- Participants with Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2.
- Participants with measurable disease
- Participants who need to start SOC cancer-directed systemic therapy
- Participants able to provide treatment and outcome information from previous lines of therapy.
- Participants who will need a tumor biopsy, excision, or resection as part of their routine clinical care.
- Participants willing to have a blood draw performed for matched normal material.
- Participants who plan to have their first radiographic assessment of their cancer at Mayo Clinic.
Exclusion
- Participants who do not have malignant tissue available or safely accessible or do not have sufficient amount of tissue from anticipated biopsy, excision or resection for testing.
- Participants who do not have measurable disease.
- Participants with insufficient health indicators to undergo therapeutic intervention for mCRC based on treating oncologist's clinical assessment.
- Participants with other concurrent cancers besides mCRC which also require ongoing cancer-directed therapy.
- Participants who cannot provide an informed consent.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06929338
Start Date
September 15 2025
End Date
June 30 2027
Last Update
September 16 2025
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