Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03337347|
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Circulating Tumor Cell||Device: CTC/DTC count||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients|
|Actual Study Start Date :||January 1, 2004|
|Actual Primary Completion Date :||February 28, 2007|
|Actual Study Completion Date :||October 23, 2015|
- Device: CTC/DTC count
The presence of CTCs/DTCs in the peripheral blood and/or bone marrow may identify colorectal cancer patients with high risk of disease recurrence who may benefit from adjuvant therapy.
- CEA mRNA positive circulating tumor cells in colorectal cancer patients [ Time Frame: 1 day ]The absolute gene expression of carcinoembryonic antigen (CEA mRNA) in circulating tumor cells (CTCs) purified from peripheral blood of patients before colorectal surgery will be measured using real-time RT-PCR method. The CEA gene expression will be normalized per microgram of total mRNA. The cut-off values identifying presence or absence of CEA mRNA positive CTCs in patients was established using the maxstat() function from the maxstat R package as a mode value of estimates obtained for 10 000 random samples. CEA mRNA levels above 190 CEA mRNA copies per microgram of RNA will indicate the presence of the CTCs in the peripheral blood sample.
- Cancer specific survival in CTC positive CRC patients [ Time Frame: 10 years ]
The cancer specific survival in months will be measured from the time of diagnosis to the time of cancer related death. Two groups of patients will be compared:
A: Patients with the presence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure.
B: Patients with the absence of CEA mRNA positive CTCs in peripheral blood before colorectal cancer surgery as described in primary outcome measure.
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): NCT03337347
|University Hospital Olomouc|
|Olomouc, Czechia, 77900|
|Principal Investigator:||Miloslav Duda, MD||University Hospital Olomouc|