Circulating Tumor Cells in mCRC for Liver Resection

Metastatic Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03295591
• Other study ID #: UW17-008
• Status: Recruiting
• Start date: June 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2018
• Source: The University of Hong Kong
• Contact: Ka On Lam, MBBS
• Phone: 22554352
• Email: lamkaon[@]hku.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: March 31, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Tumor Cell
• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Neoplastic Cells, Circulating

Intervention

Diagnostic Test:
• Circulating tumor cell
Circulating tumor cell enumeration and sequencing

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Progression free survival	Time from liver resection to date of relapse or date of death, whichever is earlier	up to 5 years
Secondary	Overall survival	Time from liver resection to date of death	up to 5 years