Circulating Tumor Cells in mCRC for Liver Resection

NCT ID: NCT03295591

Last Updated: 2018-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2020-03-31

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.

Conditions

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Metastatic Colorectal Cancer Circulating Tumor Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Circulating tumor cell

Circulating tumor cell enumeration and sequencing

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Lam Ka On

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ka On Lam, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Ka On Lam, MBBS

Role: CONTACT

Facility Contacts

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Ka On Lam, MBBS

Role: primary

Other Identifiers

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UW17-008

Identifier Type: -

Identifier Source: org_study_id

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