Circulating Tumor Cells in mCRC for Liver Resection

• Conditions: Circulating Tumor Cell; Metastatic Colorectal Cancer

• Registration Number: NCT03295591
• Lead Sponsor: The University of Hong Kong

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-28
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-17
• Last Update Posted: 2018-11-20
• Primary Completion: 2019-11-30
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Age>=18 years
2. Signed informed consent
3. Histologically or cytologically confirmed colorectal adenocarcinoma
4. Both primary tumor and liver metastases are amenable to curative resection.

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Exclusion Criteria

1. Presence of extrahepatic metastasis
2. History of other malignancies in the last 5 years
3. Patients unable to comply with the protocol

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cutoff value of CTC counts	Progression free survival at 6 months	to identify patients with early relapse (\<6 months) after liver resection as determined by the AUC under the ROC curve

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong