Circulating Tumor Cell, Metastatic Colorectal Cancer
Conditions
Keywords
Metastatic colorectal cancer, Liver resection, Circulating tumor cells
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.
Interventions
DIAGNOSTIC_TESTCirculating tumor cell
Circulating tumor cell enumeration and sequencing
Sponsors
The University of Hong Kong
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Hong Kong
Contacts
Primary ContactKa On Lam, MBBS
Outcome results
None listed