Recruiting

MicroRNA Detection

Sponsor:

City of Hope Medical Center

Code:

NCT07224724

Conditions

Colorectal Cancer Liver Metastases (CRLM)

Metastatic Colorectal Carcinoma (mCRC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EXELION

Study Details

Brief summary:

Colorectal cancer is the third most common malignancy worldwide, and prognosis largely depends on how effectively metastatic disease is managed. The liver is the most frequent and prognostically important site of metastasis, and patients responding well to chemotherapy may become candidates for curative hepatic resection. However, the presence of extrahepatic metastasis (EHM) critically influences treatment eligibility and survival. Although clinical scores such as the Fong and Beppu systems include EHM as a determinant, its detection by imaging remains limited, especially for small or occult lesions. Accurate identification of EHM is also essential when considering liver transplantation for unresectable colorectal liver metastases (CRLM), where EHM remains an exclusion criterion.

The EXELION Study aims to develop a non-invasive diagnostic model using serum exosomal microRNAs (miRNAs) to detect both hepatic and extrahepatic metastases in patients with CRLM. By integrating circulating miRNA profiling with machine learning-based analysis, this study seeks to supplement imaging diagnostics, improve treatment stratification, and enhance clinical decision-making for metastatic colorectal cancer.

Conditions

Colorectal Cancer Liver Metastases (CRLM)

Metastatic Colorectal Carcinoma (mCRC)

Study ID

NCT07224724

Start date

Jun 1, 2024

Status verified date

Jul, 2026

Completion date

Jun 18, 2028

Anticipated

Primary completion date

Jun 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults (≥18 years old)
  • Histologically- or cytologically-confirmed colorectal cancer that is metastatic
  • Availability of pre-treatment plasma samples
  • Written informed consent provided
  • Sufficient clinical and imaging data to determine presence/absence of extrahepatic metastasis

Exclusion Criteria:

  • Prior malignancies within 5 years
  • Poor sample quality or hemolysis
  • Inability to provide informed consent

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Extrahepatic liver metastasis patients(Discovery Cohort)

Patients with colorectal liver metastases (CRLM) who have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the first (discovery) cohort.

Non-extrahepatic liver metastasis patients(Discovery Cohort)

Group/Cohort Description: Patients with colorectal liver metastases (CRLM) who do not have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the first (discovery) cohort.

Extrahepatic liver metastasis patients(Training Cohort)

Extrahepatic liver metastasis patients (Training Cohort) Group/Cohort Description: Patients with colorectal liver metastases (CRLM) who have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the first (training) cohort.

Non-extrahepatic liver metastasis patients (Training Cohort)

Group/Cohort Description: Patients with colorectal liver metastases (CRLM) who do not have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the (training) cohort.

Extrahepatic liver metastasis patients (Validation Cohort)

Group/Cohort Description: Patients with colorectal liver metastases (CRLM) who have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the second, independent, validation cohort

Non-extrahepatic liver metastasis patients (Validation Cohort)

Group/Cohort Description: Patients with colorectal liver metastases (CRLM) who do not have confirmed extrahepatic metastasis at the time of diagnosis or treatment planning, included in the second, independent, validation cohort

Interventions

EXELION

A panel of exosomal microRNA, whose expression level is tested in serum or plasma

Primary outcome measure

  • Sensitivity [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

More Information

Sponsor

City of Hope Medical Center

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • CRC
  • Extrahepatic metastasis
  • liquid biopsy
  • Early detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-07-07.