Integrated Clinical-molecular Risk Stratification to Early Recurrence in Colorectal Liver Metastases

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFudan University

About this trial

The goal of this observational study is to develop an integrated clinical-molecular risk stratification to identifypatients who are at high risk of recurrence and who would benefit from adjuvant chemotherapy in patients with recectable colorectal liver metastases. The main question it aims to answer is: can the integration of multi-dimensional data-including ctDNA, driver gene profiles, and clinical factors-accurately identify postoperative patients at high risk of recurrence and guide personalized adjuvant therapy strategies?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years, inclusive (male or female).

Pathologically and radiologically confirmed colorectal cancer with liver metastases.

Must have undergone complete (R0) surgical resection of both the primary colorectal tumor and all liver metastases.

Have adequate organ function and no contraindications to potential adjuvant therapies (surgery, chemotherapy, radiotherapy, immunotherapy).

Disqualifiers

Pregnancy or breast-feeding women

History of other malignancies within 5 years (except cured skin cancer and cervicalcancer in situ)

History of uncontrolled epilepsy, central nervous system disease, or psychiatricdisorders

Clinically serious heart disease, such as symptomatic coronary artery disease, NewYork Heart Association (NYHA) class II or worse congestive heart failure or severearrhythmia requiring pharmacologic intervention, or history of myocardial infarctionwithin the last 12 months

Trial population

Patients were diagnosed with resectable colorectal liver metastases

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • gene sequencing

    Other intervention

    All patients will be performed gene sequencing in this study

  • observational study

    Other intervention

    Observational Study

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: FUSCC Prospective Cohort2 interventions

Trial outcomes

Primary outcomes

1

Model Performance

We used the area under the ROC curve (AUC) and calibration curves to evaluate the predictive performance of the model.

Time frame
2-years
2

2-year recurrence free survival

Time frame
From enrollment to the end of recurrence at 2 years

Secondary outcomes

1

3-years overall survival

Time frame
From enrollment to the end of death at 3 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: