Circulating Tumor Cell, Colorectal Cancer
Conditions
Keywords
Prognostic significance
Brief summary
To determine whether the presence of circulating/disseminated tumor cells (CTCs/DTCs) in the blood and bone marrow of colorectal cancer (CRC) patients with localized disease is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.
Interventions
DEVICECTC/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.
Sponsors
The Institute of Molecular and Translational Medicine, Czech Republic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- colorectal adenocarcinoma
Exclusion criteria
* prior neoadjuvant chemoradiotherapy * prior colorectal cancer * cancer duplicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CEA mRNA positive circulating tumor cells in colorectal cancer patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cancer specific survival in CTC positive CRC patients | 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. |
Countries
Czechia
Outcome results
None listed