Circulating Tumor Cells in mCRC for Liver Resection

Study Overview
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Brief Summary
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Resection of liver metastasis is potentially curative in patients with colorectal cancer bearing liver metastasis. However, early recurrence occurs in up to 30% in 3 months after liver resection. To optimize patient selection, the investigators propose to evaluate the the value of incorporating circulating tumor cells enumeration to clinical factors in a prospective study

Detailed Description
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This is a single-center prospective study to evaluate the predictive value of circulating tumor cells (CTC) in patients with metastatic colorectal cancer who are planned to have curative resection of liver metastasis. Blood will be taken from patients within 7 days before liver resection. CTC enumeration is done by a highly-sensitive microfluidic platform for which CTC can be subsequently enumerated with or without sequencing performed. Patients are then followed up regularly with contrast CT scan for recurrence. The primary study endpoint is to define the cutoff value of CTC count in patients with early relapse < 6months after liver resection. Seventy-seven patients will be recruited in 24 months.

Official Title
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Optimizing the Selection of Patients With Metastatic Colorectal Cancer for Liver Resection - An Immuno-clinical Scoring System Incorporating Circulating Tumor Cell Enumeration and Clinical Factors

Conditions
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Circulating Tumor Cell, Metastatic Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Circulating tumor cell


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>=18 years Signed informed consent Histologically or cytologically confirmed colorectal adenocarcinoma Both primary tumor and liver metastases are amenable to curative resection. Exclusion Criteria: Presence of extrahepatic metastasis History of other malignancies in the last 5 years Patients unable to comply with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Circulating tumor cell|Circulating tumor cell enumeration and sequencing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutoff value of CTC counts | to identify patients with early relapse (<6 months) after liver resection as determined by the AUC under the ROC curve | Progression free survival at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A immuno-clinical scoring system | A system combining CTC count with clinical factors to stratify patients before liver resection | Progression free survival at 6 months | 
| Progression free survival | Time from liver resection to date of relapse or date of death, whichever is earlier | up to 5 years | 
| Overall survival | Time from liver resection to date of death | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic colorectal cancer, Liver resection, Circulating tumor cells