Circulating Tumor Cells in mCRC for Liver Resection

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03295591
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Anticipated Duration (Months): 34
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer; Circulating Tumor Cell	Diagnostic Test: Circulating tumor cell

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 77 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Nov 30, 2019
• Anticipated Study Completion Date: Mar 31, 2020

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Progression free survival [up to 5 years]

   Time from liver resection to date of relapse or date of death, whichever is earlier

3. Overall survival [up to 5 years]

   Time from liver resection to date of death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

• The University of Hong Kong

Investigators

• Principal Investigator: Ka On Lam, MBBS, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Lam Ka On, Clinical Assistant Professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT03295591
• Other Study ID Numbers: UW17-008
• First Posted: Sep 28, 2017
• Last Update Posted: Nov 20, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Dr. Lam Ka On, Clinical Assistant Professor, The University of Hong Kong: Metastatic colorectal cancer; Liver resection; Circulating tumor cells
• Additional relevant MeSH terms: Colorectal Neoplasms; Neoplastic Cells, Circulating

Study Results

No Results Posted as of Nov 20, 2018