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Circulating Tumor Cells in mCRC for Liver Resection

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ClinicalTrials.gov Identifier: NCT03295591
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Lam Ka On, 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

Condition or disease Intervention/treatment
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.

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Study Type : Observational
Estimated 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 : June 1, 2017
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Cutoff value of CTC counts [ Time Frame: 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 [ Time Frame: Progression free survival at 6 months ]
    A system combining CTC count with clinical factors to stratify patients before liver resection

  2. Progression free survival [ Time Frame: up to 5 years ]
    Time from liver resection to date of relapse or date of death, whichever is earlier

  3. Overall survival [ Time Frame: up to 5 years ]
    Time from liver resection to date of death


Biospecimen Retention:   Samples With DNA
blood in Streck tube will be processed for isolating circulating tumor cells and its DNA content for subsequent sequencing if feasible


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with colorectal cancer and liver metastasis who are planned for liver resection
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295591


Contacts
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Contact: Ka On Lam, MBBS 22554352 lamkaon@hku.hk

Locations
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Hong Kong
The University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Ka On Lam, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Ka On Lam, MBBS The University of Hong Kong

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Responsible Party: Dr. Lam Ka On, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03295591     History of Changes
Other Study ID Numbers: UW17-008
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. Lam Ka On, The University of Hong Kong:
Metastatic colorectal cancer
Liver resection
Circulating tumor cells

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Neoplasm Metastasis
Neoplastic Cells, Circulating
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes