Metastatic Colorectal CancerNCT03295591
Circulating Tumor Cells in mCRC for Liver Resection
An observational study of Metastatic Colorectal Cancer and Circulating Tumor Cell, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, Circulating Tumor Cell
- What is being tested?
- Circulating tumor cell
- How many people
- 77 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2017to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with colorectal cancer and liver metastasis who are planned for liver resection
Who may be able to join
- Age>=18 years
- Signed informed consent
- Histologically or cytologically confirmed colorectal adenocarcinoma
- Both primary tumor and liver metastases are amenable to curative resection.
Who cannot join
- Presence of extrahepatic metastasis
- History of other malignancies in the last 5 years
- Patients unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
Ka On Lam, MBBS
About this study
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
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
Read the 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.
- Being tested
- Circulating tumor cell
- Keywords
- Metastatic colorectal cancer, Liver resection, Circulating tumor cells
- Medical subject headings
- Colorectal Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circulating tumor cellDiagnostic test
Circulating tumor cell enumeration and sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Progression free survival at 6 months
Secondary outcomes (3)
A immuno-clinical scoring system
A system combining CTC count with clinical factors to stratify patients before liver resection
Measured: Progression free survival at 6 months
Progression free survival
Time from liver resection to date of relapse or date of death, whichever is earlier
Measured: up to 5 years
Overall survival
Time from liver resection to date of death
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Jun 2017
- Primary completion30 Nov 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lam Ka On, The University of Hong Kong
- Investigators
- Ka On Lam, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295591
- Sponsor's protocol ID
- UW17-008
- Status last verified
- Nov 2018
- First submitted
- 19 Sep 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03295591
- Acronym / sponsor ID
- UW17-008
- Keywords
- Metastatic colorectal cancer, Liver resection, Circulating tumor cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Nov 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 28 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with colorectal cancer and liver metastasis who are planned for liver resection
Key inclusion criteria (4 listed)
- Age>=18 years
- Signed informed consent
- Histologically or cytologically confirmed colorectal adenocarcinoma
- Both primary tumor and liver metastases are amenable to curative resection.
Key exclusion criteria (3 listed)
- Presence of extrahepatic metastasis
- History of other malignancies in the last 5 years
- Patients unable to comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circulating tumor cellCirculating tumor cell enumeration and sequencing | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
A immuno-clinical scoring system
Time frame: Progression free survival at 6 months
Progression free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka On Lam, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer and Circulating Tumor Cell, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka On Lam, MBBS (22554352, lamkaon@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutoff value of CTC counts (time frame: Progression free survival at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.