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

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.

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Key information

Conditions

Metastatic Colorectal Cancer (CRC) Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Time frame: At baseline (at the time of study enrollment, prior to any surgical or anti-tumor treatment)

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.

Secondary outcomes

Accuracy of the prediction models based on methylation, fragmentomics, and cfRNA data for colorectal cancer recurrence and metastasis localization

Time frame: Baseline (at enrollment)

Accuracy is defined as the proportion of correctly predicted samples (true positives + true negatives) among the total number of samples in the validation cohort.
Sensitivity and specificity of individual omics technologies (methylation, fragmentomics, and cfRNA)

Time frame: Baseline (at enrollment)

Comparison of predictive performance of three individual technical approaches for localization of recurrent and metastatic lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanhong Gu, PhD

CONTACT

[email protected]

+025-68307881

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

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

Acronym: PROBE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 6, 2026
Registry last updated: Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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