A Biomarker Exploration Study for Predicting Localization of Recurrence and Metastasis in Colorectal Cancer (PROBE Study) (PROBE)

A Multicenter, Observational Clinical Study Evaluating the Application of Multi-Omics Tumor-agnostic Technology for Localizing Postoperative Local Recurrence and Distant Metastasis in Colorectal Cancer

With high incidence and mortality rate, the effective therapeutic options of colorectal cancer remain limited. Up to 50% of patients with colorectal cancer will develop metastatic disease. Recurrent lesions can be diagnosed and characterized only when tumors have reached a certain volume by present radiologic imaging techniques such as CT and MRI. The exploration of differentiated clinical applications specifically for local recurrence versus distant metastasis remains an unmet need. The aim of this study is to explore methylation, fragmentomic, and cfRNA markers associated with local recurrence and distant metastasis of colorectal cancer by multi-omics approaches. By constructing a predictive model for the localization of post-treatment recurrence and metastasis, this study will compare the accuracy of different technical approaches in predicting the localization of recurrence and metastasis after colorectal cancer treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Colorectal Cancer (CRC)

• Study Type: Observational
• Enrollment (Estimated): 586

Contacts and Locations

• Study Contact: Name: Yanhong Gu, PhD; Phone Number: +025-68307881; Email: YanhongGu@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients meeting the following tumor types: primary colorectal cancer, locally recurrent colorectal cancer, colorectal cancer liver metastasis, colorectal cancer lung metastasis, colorectal cancer peritoneal metastasis, colorectal cancer bone metastasis, colorectal cancer multi-organ metastasis, primary liver cancer, primary lung cancer, primary peritoneal cancer, primary bone tumor.

Description

Inclusion Criteria:

• Age ≥ 18 years, male or female.
• Patients with the following tumor types: primary colorectal cancer, locally recurrent colorectal cancer, colorectal cancer liver metastasis, colorectal cancer lung metastasis, colorectal cancer peritoneal metastasis, colorectal cancer bone metastasis, colorectal cancer multi-organ metastasis, primary liver cancer, primary lung cancer, primary peritoneal cancer, primary bone tumor.
• No prior surgery or anti-tumor treatment at the time of enrollment assessment.
• Subjects voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

• Previous history of malignant tumors other than those within the inclusion criteria.
• Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort
Colorectal cancer liver metastasis
Primary colorectal cancer
Locally recurrent colorectal cancer
Colorectal cancer bone metastasis
Colorectal cancer lung metastasis
Colorectal cancer peritoneal metastasis
Primary lung cancer
Primary liver cancer
Colorectal cancer multi-organ metastasis
Primary bone tumor
Primary peritoneal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Receiver Operating Characteristic Curve (AUC) of the prediction models based on methylation, fragmentomics, and cfRNA data for local recurrence and distant metastasis localization in colorectal cancer	The AUC is calculated from the Receiver Operating Characteristic (ROC) curve to evaluate the discriminatory performance of the prediction model developed by use of methylation, fragmentomics, and cfRNA data. Model performance will be assessed on the validation cohort.	At baseline (at the time of study enrollment, prior to any surgical or anti-tumor treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the prediction models based on methylation, fragmentomics, and cfRNA data for colorectal cancer recurrence and metastasis localization	Accuracy is defined as the proportion of correctly predicted samples (true positives + true negatives) among the total number of samples in the validation cohort.	Baseline (at enrollment)
Sensitivity and specificity of individual omics technologies (methylation, fragmentomics, and cfRNA)	Comparison of predictive performance of three individual technical approaches for localization of recurrent and metastatic lesions.	Baseline (at enrollment)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 29, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 28, 2027

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: June 30, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Metastatic Colorectal Cancer; Locally recurrent colorectal cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2026-SR-422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No