Clinical Significance of Detecting CEA and CK20 mRNA-positive Cells in Colorectal Cancer Patients

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.

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Key information

Conditions

Colorectal Cancer Circulating Tumor Cell Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

colorectal adenocarcinoma

Exclusion criteria

prior neoadjuvant chemoradiotherapy
prior colorectal cancer
cancer duplicity

Treatment and study plan

CTC/DTC count

Device

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2007
Study completion: 2015
First posted: Nov 9, 2017
Registry last updated: Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed