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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous history of malignant tumors other than those within the inclusion criteria.

Pregnant or breastfeeding women.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

586 Participants
are grouped into 11 trial groups

11

Trial groups

See each trial group below.

Group A: Primary colorectal cancer
Group B: Locally recurrent colorectal cancer
Group C: Colorectal cancer liver metastasis
Group D: Colorectal cancer bone metastasis
Group E: Colorectal cancer lung metastasis
Group F: Colorectal cancer peritoneal metastasis
Group G: Primary lung cancer
Group H: Primary liver cancer
Group I: Colorectal cancer multi-organ metastasis
Group J: Primary bone tumor
Group K: Primary peritoneal cancer

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline (at enrollment)
2

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.

Time frame
Baseline (at enrollment)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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