PET-CT and Circulating Tumor Cells in Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT01163305 |
Recruitment Status
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Completed
First Posted
: July 15, 2010
Last Update Posted
: May 8, 2017
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Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
Tracking Information | ||||
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First Submitted Date | June 24, 2010 | |||
First Posted Date | July 15, 2010 | |||
Last Update Posted Date | May 8, 2017 | |||
Actual Study Start Date | June 30, 2010 | |||
Actual Primary Completion Date | April 27, 2017 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy [ Time Frame: 2 years ] | |||
Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01163305 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | PET-CT and Circulating Tumor Cells in Colorectal Cancer | |||
Official Title | Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria | |||
Brief Summary | The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria. | |||
Detailed Description |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: circulating tumor cells |
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Sampling Method | Probability Sample | |||
Study Population | patients with metastatic colorectal cancer | |||
Condition |
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Intervention | Drug: Chemotherapy
The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy |
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Study Groups/Cohorts | metastatic colorectal cancer
Intervention: Drug: Chemotherapy |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
84 | |||
Original Estimated Enrollment |
96 | |||
Actual Study Completion Date | April 27, 2017 | |||
Actual Primary Completion Date | April 27, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Hong Kong | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01163305 | |||
Other Study ID Numbers | COL016 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | CCTU, Chinese University of Hong Kong | |||
Study Sponsor | Chinese University of Hong Kong | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Chinese University of Hong Kong | |||
Verification Date | April 2017 |