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

NCT07685236 | Not Yet Recruiting

• 1 other identifier: 2026-SR-422
• Study Type: observational
• Target: 586
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer (CRC)

Keywords

Metastatic Colorectal Cancer; Locally recurrent colorectal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline (at enrollment)

• Sensitivity and specificity of individual omics technologies (methylation, fragmentomics, and cfRNA)

  Baseline (at enrollment)

Study Arms (11)

Primary colorectal cancer

Locally recurrent colorectal cancer

Colorectal cancer liver metastasis

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Yanhong Gu, PhD

CONTACT

+025-68307881; YanhongGu@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 6, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 28, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share