Clinical trial · Observational

xDRIVE in Metastatic Colorectal Cancer

A Feasibility Study to Evaluate a Precision Oncology Platform (xDRIVE) in Participants With Advanced Colorectal Cancer

NCT06929338CI-TRIAL-00125346withdrawnClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Unable to finalize study agreements

Summary

Brief summary (as posted)

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

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Metastatic Colon Adenocarcinoma	Colon Adenocarcinoma	CURATED_BROADER	0.78
Metastatic Colon Cancer	Malignant Colon Neoplasm	CURATED_BROADER	0.78
Metastatic Rectal Adenocarcinoma	Rectal Adenocarcinoma	CURATED_BROADER	0.78
Metastatic Rectal Carcinoma	Rectal Carcinoma	CURATED_BROADER	0.78
Metastatic Rectum Cancer	Rectal Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Functional precision medicine	Diagnostic Test	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Metastatic colorectal cancer patients
description
Participants with mCRC who need clinical tumor biopsy or resection and need to start systemic therapy for measurable disease.
interventionNames
1. Diagnostic Test: Functional precision medicine

Primary outcomes (1)

measure
Accurate prediction of clinical benefit (complete response, partial response or stable disease) to physician-selected treatment among among enrolled patients with mCRC
timeFrame
Tumor measurements will be taken at baseline before treatment and at the first post-treatment scan. RECIST will be used to assess response. Outcomes will be tracked for the duration of the study, up to one year.
description
The primary objective is to determine the accuracy of clinical benefit prediction by xDRIVE testing in participants with advanced CRC who receive SOC therapies. Response to SOC therapy will be determined by RECIST guidelines, with disease response measured through radiographic imaging. Accurate prediction of RECIST-determined clinical response (complete response, partial response, stable disease, or progressive disease) by xDRIVE tumor in 20 of 25 participants (80%) is sufficient to reject the null hypothesis (≤50% accuracy) with 90% power (α = 0.05). Enrollment will be a total of 30 subjects.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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 Criteria:

* 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.

References

Publications (2)

BACKGROUNDAcanda de la Rocha AM, Berlow NE, Azzam DJ. Functional precision medicine: the future of cancer care. Trends Mol Med. 2025 May;31(5):404-408. doi: 10.1016/j.molmed.2024.10.015. Epub 2024 Nov 19. PMID 39567286
BACKGROUNDAcanda De La Rocha AM, Berlow NE, Fader M, Coats ER, Saghira C, Espinal PS, Galano J, Khatib Z, Abdella H, Maher OM, Vorontsova Y, Andrade-Feraud CM, Daccache A, Jacome A, Reis V, Holcomb B, Ghurani Y, Rimblas L, Guilarte TR, Hu N, Salyakina D, Azzam DJ. Feasibility of functional precision medicine for guiding treatment of relapsed or refractory pediatric cancers. Nat Med. 2024 Apr;30(4):990-1000. doi: 10.1038/s41591-024-02848-4. Epub 2024 Apr 11. PMID 38605166